Methods of navigation and treatment within a vertebral body

ABSTRACT

System and methods for channeling a path into bone include a trocar having a proximal end, distal end and a central channel disposed along a central axis of the trocar. The trocar includes a distal opening at or near the distal end of the trocar. The system includes a curved cannula sized to be received in the central channel, and having a curved distal end configured to be extended laterally outward from the distal opening in a curved path extending away from the trocar. The curved cannula has a central passageway having a diameter configured to allow a probe to be delivered through the central passageway to a location beyond the curved path.

FIELD

Various embodiments of the invention pertain generally to generatingpassageways through tissue and to treatment or monitoring ofintraosseous nerves (“ION”s), and more particularly to creating paths inbone and to treatment (e.g., modulation) of basivertebral nerves withinvertebral bodies of the spine.

BACKGROUND

Back pain is a very common health problem worldwide and is a major causefor work-related disability benefits and compensation. Back pain mayarise from strained muscles, ligaments, or tendons in the back and/orstructural problems with bones or spinal discs. The back pain may beacute or chronic. Treatments for chronic back pain vary widely andinclude physical therapy and exercise, chiropractic treatments, rest,pharmacological therapy such as pain relievers or anti-inflammatorymedications, and surgical intervention such as vertebral fusion,discectomy or disc repair. Existing treatments can be costly, addictive,temporary, ineffective, and/or can increase the pain or require longrecovery times.

SUMMARY

Although accessing the vertebral segments of the spine through thepedicle and into the lateral/anterior section of the body of thevertebra is a primary method of placing a treatment device orneuromodulation device (e.g. a bone cement delivery device, a chemicalagent delivery device, and/or an RF probe) into the vertebra, it can bedifficult to place a probe in the posterior midline section of thevertebra. Furthermore, accessing the posterior midline section of the Sisegment of the spine can be difficult with a straight linear accessroute. In one embodiment, a probe or other treatment device (e.g.,neuromodulation device) advantageously may be capable of navigating tothe posterior section of the Si vertebral segment, as well as to thesame target area within a lumbar vertebral segment. In addition, inaccordance with several embodiments, vertebral segments in the cervicaland thoracic regions of the spine may also be targeted.

In order to accurately and predictably place a treatment device (e.g.,neuromodulation device such as an energy or fluid delivery catheter orprobe) in the posterior section of a lumbar vertebral body, a sacralvertebral body or other level vertebral body, the device or probe maynavigate to the target area through varying densities of bone in someembodiments. However, due to the varying densities of bone, it can bedifficult to navigate a device or probe in bone and ensure itspositioning will be in the posterior (e.g., posterior to the midline) orposterior midline section of the vertebral body. The neuromodulationdevices described herein can be configured to perform any of the methodsteps recited herein.

Several embodiments of the invention are directed to systems and methodsto deploy and navigate a flexible treatment instrument, such as aneuromodulation device (e.g., a radiofrequency (RF) bipolar probe, amicrowave energy delivery device, or a fluid or agent delivery device)within bone. In accordance with several embodiments, a system and methodfor generating a path in bone that predictably follows a predeterminedcurved path are provided. Several embodiments herein are primarilydirected to navigating through the bone of a vertebral member of thespine, and particularly to treat the basivertebral nerve (BVN) of avertebral member. The treatment may also be applied to any tissuesegment of the body.

In accordance with several embodiments, this invention advantageouslyfacilitates navigation of a curve or angle within varying densities ofcancellous bone and creation of a straight channel at the end of thenavigated curve or angle.

In accordance with several embodiments, a method of therapeuticallytreating a vertebral body having an outer cortical bone region and aninner cancellous bone region, and a basivertebral nerve having a trunkextending from the outer cortical bone region of the vertebral body intothe inner cancellous region of the vertebral body and a plurality ofbranches extending from the trunk to define a basivertebral nervejunction or terminus, comprises the steps of: a) inserting one or moreenergy devices into the vertebral body, and b) exclusively depositingenergy within the inner cancellous bone region of the vertebral bodybetween, but exclusive of, the basivertebral nerve junction and theouter cortical bone region, to denervate the basivertebral nerve. Insome embodiments, the method comprises depositing, or delivering,energy, fluid, or other substance at or proximate (e.g., posterior to)the basivertebral nerve junction, or terminus. In some embodiments, adelivery probe for delivering a non-energy therapeutic is providedinstead of, or in addition to, the energy device.

In some embodiments, a tube-within-tube system comprises a deployablecurved tube (e.g. comprised of Nitinol or other flexible, elastic, orshape memory material) that deploys from a straight cannula. The tubecan be pre-curved to create an angular range of approximately 0° toapproximately 180° (e.g., from approximately 45° to approximately 110°,from approximately 15° to approximately 145°, from approximately 30° toapproximately 120°, from approximately 60° to approximately 90°, fromapproximately 10° to approximately 45°, overlapping ranges thereof, orany angle within the recited ranges), when fully deployed from thestraight cannula. The design of the curve can be such that a flexibleelement (e.g., probe carrying a treatment device) can navigate throughthe angular range of deployment of the curved tube. The curved tube canallow the flexible element to navigate through a curve within cancellousbone tissue without veering off towards an unintended direction.

Cancellous bone density varies from person to person. Therefore,creating a curved channel within varying density cancellous bone may notpredictably or accurately support and contain a treatment device as ittries to navigate the curved channel. With some embodiments, theflexible element is deployed into the bone through the curved tube,which supports the flexible element as it traverses through the curve,thereby preventing the flexible element from channeling its own path.When the flexible element (e.g., energy or agent delivery probe) departsfrom the tube, it can do so in a linear direction towards the targetzone or location. In accordance with several embodiments, this designallows the user to predictably and accurately deploy the flexibleelement (e.g., treatment device) towards the target zone or locationregardless of the density of the cancellous bone.

One embodiment of the invention comprises a system for channeling a pathinto bone. The system may comprise a trocar having a central channel andan opening at its distal tip, and a cannula sized to be received in thecentral channel and to be delivered to the distal opening. The cannulamay comprise a deflectable or deformable tip with a preformed curve suchthat the tip straightens while being delivered through the trocar andtransitions to a curve (e.g., regains its preformed curve) upon exitingand extending past the distal opening of the trocar to generate a curvedpath in the bone corresponding to the preformed curve of the deflectableor deformable tip. At least the distal tip or distal section of thecannula may comprise a resiliently deformable material (such as Nitinolor other shape memory material). The cannula may comprise a centralpassageway or lumen having an internal diameter configured to allow atreatment device to be delivered through the central passageway to alocation beyond the curved path in the bone.

In one embodiment, the system further includes a straight styletconfigured to be installed in the trocar, wherein the straight styletcomprises a sharp distal tip that is configured to extend beyond thedistal opening of the trocar to pierce the bone as the trocar is beingdelivered to a treatment location within the bone (e.g., within theinner cancellous bone region of a vertebral body).

Additional embodiments of the system may further include one or morestraightening stylets configured to be introduced in the cannula,wherein the straightening stylet comprises a rigid constructionconfigured to straighten the distal tip of the curved cannula whenpositioned in the trocar. In some embodiments, the straightening styletfurther comprises a sharp distal end to pierce the bone, and thestraightening stylet and curved cannula are installed or inserted in thetrocar in place of the straight stylet as the trocar is delivered intothe bone.

In some embodiments, the system further comprises a curved stylet havingan outer radius sized to fit within the central passageway of the curvedcannula. The curved stylet is configured to be installed or inserted inthe curved cannula while the curved cannula is extended past the distalopening of the trocar, the curved stylet configured to block the distalopening of the curved cannula while being delivered into the bone. Insome embodiments the curved stylet advantageously has a curved distalend corresponding to the curve of the curved cannula.

In one embodiment, the curved stylet has a sharp distal tip configuredto extend past the curved cannula to pierce the bone as the cannula isdelivered past the distal opening of the trocar. The curved stylet mayalso advantageously comprise an angled distal tip configured to furthersupport and maintain the curved stylet radius as it is delivered pastthe distal opening of the trocar and into bone. The curved stylet andthe curved cannula may have mating proximal ends (e.g., visual indiciaor corresponding physical mating elements) that align the curve of thecurved stylet with the curve of the curved cannula. In one embodiment,the angled distal tip is blunt or non-sharp.

In one embodiment, the system further includes a straight channelingstylet configured to be installed in the curved cannula after removingthe curved stylet, wherein the straight channeling stylet is flexiblydeformable to navigate the curved cannula yet retain a straight formupon exiting the curved cannula. The straight channeling stylet may havea length longer than the curved cannula such that it creates a linearpath beyond the distal end of the curved cannula when fully extended.Curved and/or straightening stylets may be used for non-spinalembodiments.

In accordance with several embodiments, a method for channeling a pathinto bone to a treatment location in the body of a patient is provided.The method includes, in one embodiment, inserting a trocar having acentral channel and an opening at its distal tip into a region of boneat or near the treatment location, and delivering a cannula through thecentral channel and to the distal opening. In one embodiment, thecannula comprises a deflectable or deformable tip with a preformed curvesuch that the tip straightens while being delivered through the trocarand transitions to a curve (e.g., regains its preformed curve) uponexiting the trocar, and extending the cannula past the distal opening ofthe trocar to generate a curved path in the bone corresponding to thepreformed curve of the deflectable tip. In some embodiments, a treatmentdevice may be delivered through a central passageway or lumen in thecannula to the treatment location beyond the curved path. The treatmentdevice may facilitate or effect energy delivery, fluid delivery,delivery of an agent, etc.

In one embodiment, inserting a trocar into a region of bone comprisesinserting a stylet into the trocar such that the stylet extends beyondthe distal opening of the trocar, and inserting the stylet and trocarsimultaneously into the region of bone such that the stylet pierces thebone as the trocar is being delivered to a treatment location.

In one embodiment, delivering a cannula through the central channelcomprises inserting a straightening stylet into the central passagewayof the cannula and inserting the straightening stylet and straightenedcannula simultaneously into the trocar. In one embodiment, thestraightening stylet comprises a rigid construction configured tostraighten the curved distal tip of the cannula. In one embodiment, thestraightening stylet further comprises a sharp distal end to pierce thebone. In one embodiment, the straightening stylet and cannula areinstalled simultaneously along with the trocar as the trocar isdelivered into the bone.

In one embodiment, extending the cannula past the distal opening isperformed by inserting a curved stylet into the central passageway ofthe curved cannula such that a distal tip of the curved stylet extendsto at least the distal opening of the curved cannula and simultaneouslyextending the curved cannula and curved stylet from the distal end ofthe trocar such that the curved stylet blocks the distal opening of thecurved cannula while being delivered into the bone.

In some embodiments, the curved stylet has a curved distal endcorresponding to the curve of the curved cannula such that the curvedstylet reinforces the curved shape of the curved cannula as the curvedcannula is extended past the distal opening of the trocar. The curvedstylet may have a sharp distal tip so that when the curved styletextends past the distal opening of the curved cannula the curved styletis configured to pierce the cancellous bone tissue as the curved cannulais delivered past the distal opening of the trocar. In some embodiments,the distal tip of the curved stylet is angled and/or blunt.

In accordance with some embodiments, the curved stylet is then removedfrom the curved cannula, and a straight channeling stylet is insertedinto the curved distal end of the cannula. The straight channelingstylet can be flexibly deformable to navigate the curved cannula, yetretain a straight form upon exiting the curved cannula. The straightchanneling stylet can advantageously be longer than the curved cannulato create a linear channel beyond the distal tip of the curved cannula.

In some embodiments, the trocar is inserted through a cortical boneregion and into a cancellous bone region of a vertebral body, and thecurved cannula is extended though at least a portion of the cancellousbone region to a location at or near a target treatment location. Atarget treatment location may comprise a basivertebral nerve within thevertebra, and treatment may be delivered to the target treatmentlocation to modulate (e.g., denervate, ablate, stimulate, block,disrupt) at least a portion of the basivertebral nerve (e.g., terminusor junction or a portion of the basivertebral nerve between the terminusor junction and the posterior wall). In one embodiment, a portion of thebasivertebral nerve is modulated by delivering focused, therapeuticheating (e.g., a thermal dose) to an isolated region of thebasivertebral nerve. In another embodiment, a portion of thebasivertebral nerve is modulated by delivering an agent to the treatmentregion to isolate treatment to that region. In accordance with severalembodiments of the invention, the treatment is advantageously focused ona location of the basivertebral nerve that is upstream of one or morebranches of the basivertebral nerve.

Several embodiments may include a kit for channeling a path into bone.The kit comprises a trocar having a central channel and opening at itsdistal tip, and a cannula selected from a set of cannulas sized to bereceived in the central channel and delivered to the distal opening. Thecannula may have a deflectable or deformable distal tip with a preformedcurve such that the tip straightens while being delivered through thetrocar and regains its preformed curve upon exiting and extending pastthe distal opening of the trocar to generate a curved path in the bonecorresponding to the preformed curve of the deflectable tip. The cannulamay comprise a central passageway or lumen having an internal diameterconfigured to allow a treatment device to be delivered through thecentral passageway or lumen to a location beyond the curved path withinbone, wherein the set of cannulas comprises one or more cannulas thathave varying preformed curvatures at the distal tip.

In some embodiments, the one or more cannulas have a varying preformedradius at the distal tip. In addition, the one or more cannulas may eachhave distal tips that terminate at varying angles with respect to thecentral channel of the trocar. The length of the distal tips may also bevaried. The angle of the distal tip with respect to the central channelof the trocar may vary from 0 degrees to 180 degrees. In accordance withseveral embodiments, t (e.g., from 10 degrees to 60 degrees, from 15degrees to 45 degrees, from 20 degrees to 80 degrees, from 30 degrees to90 degrees, from 20 degrees to 120 degrees, from 15 degrees to 150degrees, overlapping ranges thereof, or any angle between the recitedranges). The kit may further include a straight stylet configured to beinstalled in the trocar, the straight stylet comprising a sharp distaltip that is configured to extend beyond the distal opening of the trocarto pierce the bone as the trocar is being delivered to a treatmentlocation within the bone. The kits may be adapted for non-spinalembodiments.

In some embodiments, the kit includes a set of curved stylets having anouter radius sized to fit within the central passageway of the curvedcannula, wherein each curved stylet is configured to be installed in thecurved cannula while the curved cannula is extended past the distalopening of the trocar. The curved stylet may be configured to block thedistal opening of the curved cannula while being delivered into thebone. In one embodiment, each curved stylet may have a varying curveddistal end corresponding to the curve of a matching curved cannula inthe set of curved cannulas.

In some embodiments, the kit includes a set of straight channelingstylets wherein one of the set of stylets is configured to be installedin the cannula after removing the curved stylet. The straight channelingstylet can be flexibly deformable to navigate the curved cannula yetretain a straight form upon exiting the curve cannula. Each of thestraight channeling stylets can have a varying length longer than thecurved cannula such that the straight channeling stylet creates apredetermined-length linear path beyond the distal end of the curvedcannula when fully extended.

In accordance with several embodiments, a system for channeling a pathinto bone comprising a trocar with a proximal end, a distal end and acentral channel disposed along a central axis of the trocar andextending from the proximal end toward the distal end is provided. Thetrocar, in one embodiment, comprises a radial opening at or near thedistal end of the trocar, the radial opening being in communication withthe central channel. In some embodiments, the system further comprises acurveable or steerable cannula sized to be received in said centralchannel and delivered from the proximal end toward said radial opening.In several embodiments, the curveable cannula comprises a curveableand/or steerable distal end configured to be extended laterally outwardfrom the radial opening in a curved path extending away from the trocar,and a central passageway having a diameter configured allow a treatmentdevice (e.g., probe, catheter) to be delivered through the centralpassageway to a location beyond the curved path.

In several embodiments, the curveable cannula comprises a proximal endhaving a proximal body. In one embodiment, the proximal end of thetrocar comprises a housing. The housing may comprise a proximal recessconfigured to allow reciprocation (e.g., alternating back-and-forthmotion or other oscillatory motion) of the proximal body of thecurveable cannula. The proximal recess of the housing may be incommunication with the central channel of the trocar. In severalembodiments, a proximal body of the curveable cannula is configured tobe releasably restrained with respect to translation within the trocarhousing. In several embodiments, the system comprises a probe sized tofit within the central channel of the cannula. The probe may comprise aproximal end configured to be releasably restrained with respect totranslation within the proximal body of the curveable cannula. In oneembodiment, the probe comprises mating threads that mate withcorresponding mating threads of a distal recess of the drive nut so asto allow controlled translation of the probe with respect to the drivenut.

In several embodiments, a spine therapy system is provided. In oneembodiment, the system comprises a trocar having a proximal end, adistal end and a central channel. The central channel can be disposedalong a central axis of the trocar and extend from the proximal endtoward the distal end. In one embodiment, the trocar comprises a radialopening at or near the distal end of the trocar, the radial openingbeing in communication with the central channel. In one embodiment, thetrocar is configured to be deployed through a cortical bone region andinto a cancellous bone region of a vertebral body. In one embodiment, acurveable cannula is configured (e.g., sized) to be received in saidcentral channel and delivered from the proximal end toward the radialopening. The curveable cannula may comprise a central passageway and acurveable and/or steerable distal end configured to be extendedlaterally outward from the radial opening in a curved path extendingaway from the trocar. The curved path may be generated through at leasta portion of the cancellous bone region of the vertebral body. In oneembodiment, a treatment device or probe is configured to be deliveredthrough the central passageway to a location beyond the curved path. Thetrocar, curveable cannula, and/or treatment device can have a sharpdistal end or tip configured to penetrate bone tissue. In someembodiments, the distal ends of the trocar, curveable cannula, and/ortreatment device are rounded or blunt. In some embodiments, the distalends of the trocar or curved or curveable cannula have a full radius onthe inside and/or outside diameter to prevent other devices fromcatching when being pulled back into the distal end after beingdelivered out of the distal end.

In accordance with several embodiments, a method for channeling a pathinto bone to a treatment location in the body of a patient is provided.The bone may be within or proximal a vertebral body, or may benon-spinal (e.g., knee or other joints). In one embodiment, the methodcomprises inserting a trocar into a region of bone near the treatmentlocation. In one embodiment, the trocar comprises a proximal end, adistal end, and a central channel disposed between the two ends. In oneembodiment, the method comprises delivering a curveable cannula throughthe central channel and to a radial opening at or near the distal end ofthe curveable cannula. In one embodiment, the method comprises deployingthe curveable cannula laterally outward from the radial opening in acurved path extending away from the trocar. In one embodiment, themethod comprises steering the curveable cannula (e.g., via a pull cordcoupled to the distal tip of the curveable cannula or via other steeringmechanisms) to bias the curveable cannula in the curved path. Energyand/or another diagnostic or therapeutic agent is then optionallydelivered to the treatment location.

In accordance with several embodiments, a method of treating back painis provided. In some embodiments, the method comprises identifying avertebral body for treatment (e.g., a target for treatment of chronicback pain). In some embodiments, the method comprises identifying atreatment zone, area or site within the inner cancellous bone region ofthe vertebral body. In some embodiments, the treatment zone, area orsite is within a posterior section of the vertebral body (e.g.,posterior to an anterior-posterior midline). In some embodiments, thetreatment zone comprises a location corresponding to the mid-height ofthe vertebra from an anterior-posterior view. In some embodiments, aborder of the treatment zone is at least 1 cm (e.g., between 1-2 cm, 2-3cm, 3-4 cm, or more) from the posterior wall of the vertebral body. Insome embodiments, the treatment zone is determined by measuring thedistance from the posterior wall to the basivertebral foramen as apercentage of the total distance from the posterior wall to the anteriorwall of the vertebral body.

In some embodiments, identifying a treatment zone is performedpreoperatively using imaging methods such as magnetic resonance imaging(MRI) or computed tomography (CT) imaging modalities. In someembodiments, the treatment zone, site, or location corresponds to alocation that is about mid-height between the superior and inferiorendplate surfaces of the vertebral body (which may be identified byimaging methods from an anterior-posterior view). In some embodiments,the treatment zone, site or location is identified by measuring thedistance from the posterior wall of the vertebral body to thebasivertebral foramen from images (e.g., anteroposterior and/or lateralMRI or CT images) of the vertebral body as a percentage of the totaldistance from the posterior wall to the anterior wall of the vertebralbody. In some embodiments, inserting the neuromodulation device withinthe treatment zone is performed under visualization (e.g., usingfluoroscopy). In some embodiments, positioning a distal end portion ofthe neuromodulation device within the treatment zone comprisespositioning the distal end portion (and any active elements such aselectrodes located at the distal end portion) at a locationcorresponding to the measured distance percentage described above. Insome embodiments, the percentage is a standardized distance percentagethat is not individually measured for the individual subject orvertebral body being treated. In some embodiments, the treatment zone,site, or location corresponds to a location at or proximate (e.g.,posterior to) a terminus of the basivertebral foramen.

In some embodiments, the method comprises inserting a curved cannulathrough the outer cortical bone region of the vertebral body and intothe inner cancellous bone region of the vertebral body. The curvedcannula can comprise a flexible catheter, tube, or other conduit havinga pre-curved or steerable distal end. The curved cannula may compriseNitinol, PEEK, or other thermoplastic, shape memory or resilientlydeformable material. In some embodiments, the method comprises insertinga neuromodulation device within the curved cannula. The neuromodulationdevice can comprise an energy delivery device, a fluid delivery device,or an agent delivery device. The fluid may or may not comprise an agent,such as a chemical agent. In one embodiment, the chemical agentcomprises a lytic agent.

In various embodiments, the energy delivery device is configured todeliver radiofrequency energy, microwave energy, light energy, thermalenergy, ultrasonic energy, and/or other forms of electromagnetic energy,and/or combinations of two or more thereof. In accordance with severalembodiments, the energy is configured to heat tissue within bone (e.g.,a vertebral body) sufficient to modulate (e.g., denervate, ablate)intraosseous nerves (e.g., basivertebral nerves or other nerves locatedpartially or fully within bone). In other embodiments, the energy isconfigured to treat tissue outside the spine, for example in non-spinaljoints or in non-orthopedic applications (e.g., cardiac, pulmonary,renal, or treatment of other organs and/or their surrounding nerves).The temperature of the energy may be in the range of between 40° C. and100° C., between 50° C. and 95° C., between 60° C. and 80° C., between75° C. and 95° C., between 80° C. and 90° C., overlapping rangesthereof, or any temperature between the recited ranges. In someembodiments, the temperature and length of treatment can be varied aslong as the thermal dose is sufficient to modulate (e.g., at leasttemporarily denervate, ablate, block, disrupt) the nerve. In someembodiments, the length of treatment (e.g., delivery of energy) rangesfrom about 5 to about 30 minutes (e.g., about 5 to 15 minutes, about 10to 20 minutes, about 15 to 25 minutes, about 20 to 30 minutes,overlapping ranges thereof, 15 minutes, or about any other length oftime between the recited ranges). In some embodiments, theneuromodulation device comprises a sensor to measure nerve conduction ofthe nerve at the treatment zone.

The energy delivery device may comprise one or more probes (e.g., aradiofrequency probe). In some embodiments, the probe comprises one ormore electrodes configured to generate a current to heat tissue withinbone. In one embodiment, the probe comprises a bipolar probe having twoelectrodes. The two electrodes may comprise an active electrode and areturn electrode. In one embodiment, the active electrode comprises atip electrode positioned at the distal tip of the radiofrequency probeand the return electrode comprises a ring electrode spaced proximallyfrom the active electrode with insulation material between the twoelectrodes. In one embodiment, the return electrode comprises a tipelectrode positioned at the distal tip of the probe (e.g., aradiofrequency probe) and the active electrode comprises a ringelectrode spaced proximally from the return electrode. The twoelectrodes may be spaced about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm,8 mm, 9 mm or 1 cm apart. In various embodiments, the electrodescomprise cylindrical electrodes, tip electrodes, plate electrodes,curved electrodes, circular electrodes, or other shapes. In someembodiments, the electrodes comprise an electrode array. In variousembodiments, the frequency of the energy can be between about 100 kHzand 1 MHz, between 400 kHz and 600 kHz, between 300 kHz and 500 kHz,between 350 kHz and 600 kHz, between 450 kHz and 600 kHz, overlappingranges thereof, or any frequency within the recited ranges.

In one embodiment, the energy delivery device comprises an ultrasoundprobe having one or more ultrasound transducers. The ultrasound probemay be configured to deliver high-intensity focused ultrasonic energy,low-intensity ultrasonic energy or other forms of ultrasonic energysufficient to modulate the nerve. The ultrasound energy may be used forcavitation or non-cavitation. In one embodiment, the energy deliverydevice comprises a laser or light energy delivery device configured todeliver light energy sufficient to modulate the nerve. In oneembodiment, the energy delivery device is configured to deliverradiation sufficient to modulate the nerve. In one embodiment, theenergy delivery device comprises a microwave energy delivery devicecomprising one or more microwave antennas configured to delivermicrowave energy sufficient to effect modulation of the nerve.

In one embodiment, a fluid delivery device is used to effect atemperature change in a location in the disc. For example, the fluiddelivery device may be used to deliver a cryoablative fluid. In anotherembodiment, the fluid delivery device may be used to deliver a coolingfluid to cool a region in conjunction with a therapy that generatesheat. In some embodiments, a distal portion of the curved cannula isshaped so as to guide a distal end of the neuromodulation device towardsthe midline of the vertebral body (or other treatment area outside thespine). In some embodiments, a proximal end of the fluid delivery deviceis coupled to a fluid source or reservoir (e.g., syringe, fluid pump).In some embodiments, the fluid delivery device comprises a catheter,tube, sleeve, needle, cannula, wicking device, or other conduitconfigured to deliver fluid. The fluid may comprise neurolytic agents,chemotherapy agents, radioactive substances, medications, drugs,pharmaceuticals, alcohols, acids, solvents, cooling agents, nerveblocking agents, and/or other chemical agents.

In some embodiments, the method comprises advancing the distal end ofthe neuromodulation device out of a distal opening of said cannula andinto the inner cancellous bone region of the vertebral body or treatmentarea. The distal opening may be an axial opening or a radial opening. Insome embodiments, the method comprises positioning the distal end ofsaid neuromodulation device within, at or proximate the treatment zone,area site, or location of the vertebral body or treatment area.

In some embodiments, the method comprises effecting modulation of atleast a portion of a nerve (e.g., basivertebral nerve or intraosseousnerve) using the neuromodulation device. The modulation (e.g.,neuromodulation) can comprise partial or complete and/or temporary orpermanent blocking, disruption, denervation or ablation of the nerve. Invarious embodiments, the modulation comprises radiofrequency ablation,microwave energy ablation, chemical ablation, cryoablation, ultrasonicablation, acoustic ablation, laser ablation, thermal ablation, thermalheating, cooling, mechanical severing, neuromodulation, and/orstimulation of the nerve. In one embodiment, stimulation of the nerve isperformed to block the travel of signals indicative of pain. Stimulationmay comprise mechanical, electrical, or electromechanical stimulationand may be performed by any of the modalities or methods describedherein with reference to ablation or modulation. The stimulation may becontinuous or pulsed. In various embodiments, the modulation may beperformed by a radioactive implant or by an external radiation beam(e.g., electron beam, gamma-knife, etc.).

In accordance with several embodiments, a method of treating pain (e.g.,back pain) is provided. In some embodiments, the method comprisesidentifying a treatment zone, such as a vertebral body for treatment(e.g., an identified source of pain or location likely to treat pain).In some embodiments, the treatment zone comprises a basivertebralresidence zone within which a portion of the basivertebral nerve (e.g.,main trunk, junction, terminus of basivertebral foramen, etc.) is likelyto reside. In some embodiments, the treatment zone is identified withoutknowing the precise location of the basivertebral nerve. In someembodiments, the method comprises identifying a treatment zone, site,region or location within the inner cancellous bone region within aposterior section of the vertebral body. The posterior section maycomprise a section posterior to an anterior-posterior midline or aregion within a distance between about 10% and about 50%, between about20% and about 50%, between about 10% and about 40% of the distance fromthe posterior wall. In some embodiments, the method comprises insertinga distal end portion of the neuromodulation device (e.g., energy and/orfluid delivery probe), and any active elements disposed thereon, withinor proximate the treatment zone. In some embodiments, the methodcomprises thermally inducing modulation of a function of a basivertebralnerve within the vertebral body with the energy delivery probe.

In some embodiments, the method comprises generating a curved pathwithin the inner cancellous bone region towards a midline of thevertebral body with a cannula having a pre-curved distal end portion tofacilitate access to the posterior section of the vertebral body. Insome embodiments, insertion of the neuromodulation device through acurved cannula allows for access straight through (e.g., concentricallythrough) the pedicle in a transpedicular approach instead of anoff-center access, which may be difficult for some levels of vertebraedue to anatomic constraints. In some embodiments, the method comprisesinserting the neuromodulation device within the curved path created bythe cannula. In some embodiments, the cannula is shaped so as to guide adistal end portion of the neuromodulation device towards the midline ofthe vertebral body. In some embodiments, the method comprises insertinga stylet within the cannula that is adapted to penetrate bone tissue ofthe vertebral body beyond the curved path created by the cannula.

In accordance with several embodiments, a method of therapeuticallyheating a vertebral body to treat back pain is provided, In someembodiments, the method comprises identifying a residence zone of abasivertebral nerve within the inner cancellous bone region of thevertebral body. In some embodiments, the method comprises inserting twoelectrodes into the vertebral body. In some embodiments, the methodcomprises positioning the two electrodes within or proximate theresidence zone. In some embodiments, the method comprises generating aheating zone between the two electrodes to heat the basivertebral nerve.For example, a first electrode may be activated to generate a currentbetween the first electrode and a second electrode. The current maygenerate heat within the bone tissue. The heating zone may comprise aninner resistive heating zone and an outer conductive heating zone. Insome embodiments, the heating zone is configured to have a radius ordiameter between about 0.5 cm and 2 cm (e.g., 0.5 cm, 0.6 cm, 0.7 cm,0.8 cm, 0.9 cm, 1 cm, 1.1 cm, 1.2 cm, 1.3 cm, 1.4 cm, 1.5 cm, 1.6 cm,1.7 cm, 1.8 cm, 1.9 cm, 2 cm). In accordance with several embodiments,forming heating zones (and in some cases, lesions) of a specific sizeand shape can be improved by adjusting parameters such as diameter andactive length of electrodes, initial and steady-state power input,length of treatment, and device control temperature.

In some embodiments, inserting two electrodes into the vertebral bodycomprises inserting a first energy delivery probe having a firstelectrode within the inner cancellous bone region and positioning asecond energy delivery probe having a second electrode within the innercancellous bone region. In some embodiments, inserting two electrodesinto the vertebral body comprises inserting a single energy deliveryprobe having two electrodes within the inner cancellous bone region.

In some embodiments, positioning the two electrodes within or proximatethe residence zone comprises positioning the electrodes at a locationsuch that a single heating treatment modulates (e.g., denervates,ablates) the entire basivertebral nerve system without requiringseparate downstream modulation (e.g., denervation, ablation) treatments.In some embodiments, positioning the two electrodes of within orproximate the residence zone comprises positioning the two electrodes tostraddle the residence zone. In some embodiments, positioning the twoelectrodes within or proximate the residence zone comprises positioninga first electrode on a first side of the vertebral body and positioninga second electrode on a second side of the vertebral body (wherein thefirst side and second side are on opposite sides of any line drawnthrough a midpoint of the vertebral body).

In accordance with several embodiments of the invention, methods andsystems allow for positioning of a treatment device in contact with orin close proximity to a basivertebral nerve without knowing the preciselocation of the basivertebral nerve. In attempting to place at least oneelectrode in close proximity to the basivertebral nerve, the approachesdisclosed in the teachings of the art are somewhat problematic. Inparticular, although the location of the basivertebral nerve is somewhatwell known, the basivertebral nerve is radiolucent and so its preciselocation cannot be easily identified by an X-ray. Since thebasivertebral nerve is also extremely thin, knowingly placing theelectrode in close proximity to the basivertebral nerve may beproblematic in some cases. Moreover, in one embodiment, since certain RFelectrodes appear to heat only a fairly limited volume of bone,misplacement of the electrode vis-à-vis the basivertebral nerve mayresult in heating a volume of bone that does not contain thebasivertebral nerve. “Close proximity” with regard to the intraosseousor basivertebral nerve can mean located at a position such that thenerve is modulated upon activation of the neuromodulation device ordelivery of fluid or other sub stances by the neuromodulation device.

The terms “modulation” or “neuromodulation”, as used herein, shall begiven their ordinary meaning and shall also include ablation, permanentdenervation, temporary denervation, disruption, blocking, inhibition,therapeutic stimulation, diagnostic stimulation, inhibition, necrosis,desensitization, or other effect on tissue. Neuromodulation shall referto modulation of a nerve (structurally and/or functionally) and/orneurotransmission. Modulation is not limited to nerves and may includeeffects on other tissue.

Several embodiments of the invention relate to the production of a largebut well-controlled heating zone within bone tissue to therapeuticallytreat (e.g., modulate) an ION within the heating zone. Other embodimentsprovide modulation of non-spinal tissue (e.g., nerves).

Accordingly, some embodiments of the invention are advantageous becausethey allow the clinician to create a sufficiently large heating zone fortherapeutically treating the ION (e.g., basivertebral nerve) withoutrequiring direct access to the ION. Some embodiments of the inventionare particularly advantageous because such embodiments: (i) do notrequire knowing the precise location of the ION, (ii) do not requiredirectly accessing the ION, and/or (iii) have a controlled heatingprofile that allows a clinician to avoid heating adjacent structuressuch as the healthy adjacent cancellous bone tissue, the spinal cord oropposing vertebral endplates.

In accordance with several embodiments, a system for channeling a pathinto bone is provided. The system may comprise a trocar comprising aproximal end, a distal end and a central channel. In one embodiment, thecentral channel is disposed along a central axis of the trocar andextends from the proximal end toward the distal end. In one embodiment,the trocar comprises a distal opening at or near the distal end of thetrocar, the distal opening being in communication with the centralchannel. The system may comprise a curved cannula sized to be receivedin the central channel and delivered from the proximal end toward thedistal opening of the trocar. In one embodiment, the curved cannulacomprises a straight tubular body at a proximal end of the curvedcannula and a curved distal end. The curved distal end may be configuredto be extended laterally outward from the distal opening in a curvedpath extending away from the trocar; wherein the curved cannulacomprises a central passageway having a diameter configured to allow aprobe to be delivered through the central passageway to a locationbeyond the curved path.

In some embodiments, the distal end of the curved cannula is deformableso as to be delivered in a straight configuration through the trocar anddeployed in a curved configuration outward from the distal opening at anangle with respect to the central axis. In various embodiments, theproximal end of the trocar comprises a handle having a proximal recessin communication with the central channel of the trocar to allowreciprocation of the curved cannula within the central channel and alateral slot in communication with the proximal recess. In oneembodiment, the lateral slot extends radially outward from the proximalrecess at a proximal surface of the handle. The slot may be configuredto allow insertion of the curved cannula such that a central axis of thestraight tubular body is at an angle with respect to the central axis ofthe trocar when the curved distal end of the curved cannula is insertedinto the proximal recess. In one embodiment, the curved cannula can beinserted within the trocar without requiring a straightening sleeve orother structure to straighten the curved cannula prior to insertion.

In one embodiment, the lateral slot comprises a curvilinear bottomsurface configured to allow the curved distal end of the curved cannulato be slideably advanced into the proximal recess and the centralchannel, thereby facilitating ease of insertion of a curved instrumentinto a straight channel. In one embodiment, the curvilinear bottomsurface of the lateral slot comprises a radius substantially matchingthe radius of the curved distal end of the curved cannula.

In several embodiments, the system comprises a curved stylet comprisinga straight proximal body and a preformed curved distal end. In oneembodiment, the curved cannula comprises a cannula channel configured toallow delivery of a treatment device to the location beyond the curvedpath. The proximal end of the curved cannula may comprise a cannulahandle having a central recess in communication with the cannula channelto allow reciprocation of the curved stylet within the cannula channeland a lateral cannula slot in communication with the central recess. Inone embodiment, the cannula slot extends radially outward from thecentral recess at a proximal surface of the cannula handle such that thelateral cannula slot is configured to allow insertion of the curvedstylet in a manner such that a central axis of the straight proximalbody is at an angle with respect to a central axis of the cannulachannel when the preformed curved distal end of the curved stylet isinserted into the central recess.

In some embodiments, the lateral cannula slot comprises a curvilinearbottom surface configured to allow the preformed curved distal end ofthe curved stylet to be slideably advanced into the central recess andcannula channel. The curvilinear bottom surface of the cannula handlemay comprise a radius substantially matching the radius of the preformedcurved distal end of the curved stylet. In some embodiments, the curvedcannula comprises a stop nut threaded about a threaded portion distal tothe cannula handle and proximal to the straight proximal body. In oneembodiment, the stop nut is configured to have a first position on thethreaded portion. The stop nut may be configured to restrain advancementof the curved cannula within the trocar such that the curved distal endof the cannula does not extend past the distal end of the trocar whenthe stop nut is in the first position. In one embodiment, the stop nutcomprises a second position on the threaded portion configured to allowfurther translation of the curved cannula with respect to the trocar.The stop nut may be rotated or otherwise translated to the secondposition prior to extending the curved distal end of the curved cannulalaterally outward from the distal opening of the trocar. In someembodiments, the system comprises a treatment probe (e.g., an RF energydelivery probe) configured to be delivered through the centralpassageway to a location at or beyond the curved path.

In accordance with several embodiments, a method for channeling a pathinto a vertebral body of a patient using the trocar, curved cannulaand/or curved stylet described above is provided. The method comprisesinserting a trocar into the vertebral body. The trocar may have any ofthe structural features of the trocars described herein (e.g., slottedhandle) to facilitate insertion of a curved instrument without requiringstraightening of the curved instrument prior to insertion, therebyreducing the number of steps and/or instruments in a spine therapysystem. In some embodiments, the method comprises inserting the curveddistal end of a curved cannula into a proximal recess of a trocar handlethrough a lateral slot of the trocar handle and such that a central axisof the straight tubular body of the curved cannula is at an angle withrespect to the central axis of the trocar. In some embodiments, themethod comprises advancing the curved cannula into the proximal recessof the trocar, thereby straightening the curved distal end of the curvedcannula. In one embodiment, the method comprises advancing the curvedcannula within the central channel of the trocar from the proximal endtoward the distal opening of the trocar and extending the curved distalend of the curved cannula laterally outward from the distal opening ofthe trocar to generate a curved path radially outward from the trocar.In one embodiment, the method comprises delivering a treatment probethrough the curved cannula to a location beyond the curved path.

In some embodiments, the method comprises retracting the curved styletfrom the curved cannula and delivering a straight stylet into the curvedcannula to generate a straight path beyond the curved path radiallyoutward from the trocar. In some embodiments, the method comprisesretracting the straight stylet from the curved cannula and deliveringthe treatment probe through the curved cannula to a location beyond thecurved path.

In accordance with several embodiments, a system for delivering aself-guided treatment device into bone is provided. The system maycomprise a trocar comprising a proximal end, a distal end and a centralchannel. In one embodiment, the central channel is disposed along acentral axis of the trocar and extends from the proximal end toward thedistal end and the trocar comprises a distal opening at or near thedistal end of the trocar, the distal opening being in communication withthe central channel. The system may also comprise a treatment probesized to be received in the central channel and delivered from theproximal end toward the distal opening of the trocar. In one embodiment,the treatment probe comprises a stylet comprising a straight proximalend and a curved distal end. In one embodiment, the curved distal end isdeformable so as to be delivered in a straight configuration through thetrocar and deployed in a curved configuration outward from the distalopening at an angle with respect to the central axis of the trocar. Insome embodiments, the curved distal end comprises a treatment deviceconfigured to deliver a therapeutic dose of energy to a treatmentlocation.

In some embodiments, the curved distal end of the treatment probecomprises a sharpened distal tip configured to channel through acancellous bone region of a vertebral body. In some embodiments, thetherapeutic dose of energy delivered by the treatment device isconfigured to denervate a basivertebral nerve associated with thevertebral body. In one embodiment, the proximal end of the trocarcomprises a handle comprising a proximal recess in communication withthe central channel to allow reciprocation of the curved cannula withinthe central channel and a lateral slot in communication with theproximal recess. In one embodiment, the lateral slot extends radiallyoutward from the proximal recess at a proximal surface of the handle ofthe trocar such that the lateral slot is configured to allow insertionof the treatment probe such that a central axis of the straight proximalend of the stylet is at an angle with respect to the central axis of thetrocar when the curved distal end of the treatment probe is insertedinto the proximal recess of the trocar. The lateral slot may comprise acurvilinear bottom surface configured to allow the curved distal end ofthe treatment probe to be slideably advanced into the proximal recessand the central channel of the trocar. In one embodiment, thecurvilinear bottom surface comprises a radius substantially matching theradius of the curved distal end of the treatment probe.

In several embodiments, the system comprises a straight styletcomprising a straight proximal body and a sharpened distal end. Thestylet may be configured to protrude from the distal opening of thetrocar when installed in the trocar. In one embodiment, the styletcomprises a striking surface for advancing the trocar through a corticalbone region of the vertebral body. In one embodiment, the treatmentprobe comprises a handle having a striking surface for advancing thetreatment probe through the cancellous bone region of the vertebralbody.

In one embodiment, the distal end of the treatment probe comprises aplurality of circumferentially relieved sections. In one embodiment, thedistal end of the treatment probe comprises a pair of ring electrodesforming a bipolar RF treatment device. In some embodiments, the styletof the treatment probe comprises a longitudinal channel extending fromthe curved distal end to the straight proximal end, the channelconfigured to house a flexible lead coupled to the pair of ringelectrodes. In one embodiment, the probe handle comprises a connectorfor coupling a power source to the flexible lead.

In accordance with several embodiments, a method for delivering aself-guided treatment device into bone is provided. The method maycomprise inserting a trocar into bone. The trocar may comprise any ofthe structural features of the trocars described herein (e.g., slottedhandle) to facilitate insertion of a curved instrument without requiringstraightening of the curved instrument prior to insertion, therebyreducing the number of steps and/or instruments in a treatment system.In one embodiment, the method comprise inserting a curved distal end ofa treatment probe (such as the treatment probes described above) into aproximal recess of the trocar through a lateral slot and such that acentral axis of a straight tubular body of the treatment probe is at anangle with respect to the central axis of the trocar. The method maycomprise advancing the treatment probe into the proximal recess of thetrocar, thereby straightening the curved distal end of the treatmentprobe upon insertion rather than prior to insertion (e.g., with a sleeveor other constraint). In one embodiment, the method comprises advancingthe treatment probe within the central channel of the trocar from theproximal end toward the distal opening of the trocar and extending thecurved distal end of the treatment probe laterally outward from thedistal opening of the trocar to generate a curved path radially outwardfrom the trocar. In one embodiment, the method comprises delivering atherapeutic dose of energy to a treatment location within the bone. Insome embodiments, the therapeutic dose of energy is configured todenervate a basivertebral nerve associated with the vertebral body. Inone embodiment, delivering a therapeutic dose of energy to the treatmentlocation comprises delivering RF energy to denervate the basivertebralnerve.

In several embodiments, the system may comprise a curved styletcomprising a straight proximal body and a curved distal end. The curvedstylet may further comprise an inner core and an outer layer. In severalembodiments, the inner core comprises an elastic metal alloy. In severalembodiments, the outer layer comprises a polymer. In some embodiments,the diameter of the inner core is constant along the length of the innercore. In accordance with several embodiments, during manufacturing, thestiffness of the curved stylet can be altered by manipulating thediameter of the inner core, the wall thickness of the outer layer, or acombination thereof. The curved stylet may be configured to protrudefrom the distal opening of the trocar when installed in the trocar.

In accordance with several embodiments, a method for manufacturing acurved stylet is provided. The method may comprise providing an innercore, and in some embodiments, providing an inner core of a constantdiameter. The method may comprise encasing at least a portion of theinner core with an outer layer. In several embodiments, the inner corecomprises an elastic metal alloy. In several embodiments, the outerlayer comprises a polymer. In some embodiment, the method may comprisemanipulating the diameter of the inner core, the wall thickness of theouter layer, or a combination thereof in order to achieve desiredstiffness.

The methods summarized above and set forth in further detail belowdescribe certain actions taken by a practitioner; however, it should beunderstood that they can also include the instruction of those actionsby another party. Thus, actions such as “delivering a therapeutic doseof energy” include “instructing the delivery of a therapeutic dose ofenergy.” Further aspects of embodiments of the invention will bediscussed in the following portions of the specification. With respectto the drawings, elements from one figure may be combined with elementsfrom the other figures.

BRIEF DESCRIPTION OF THE DRAWINGS

Several embodiments of the invention will be more fully understood byreference to the following drawings which are for illustrative purposesonly:

FIG. 1 illustrates an embodiment of a system for generating a curvedpath in bone.

FIG. 2 is a sectional view of an embodiment of the system of FIG. 1.

FIG. 3 illustrates a sectioned view of an embodiment of a vertebral bodywith a path bored through the cortical shell.

FIGS. 4A-4F illustrate a method for accessing the basivertebral nerve inaccordance with several embodiments.

FIG. 5 shows an alternative embodiment of a system for generating acurved path in bone.

FIG. 6 shows an embodiment of the system of FIG. 5 being installed in avertebral body.

FIGS. 7A-7B show embodiments of a curved stylet.

FIG. 8 illustrates a perspective view of an embodiment of a system forgenerating a curved path in bone.

FIG. 9 is an exploded view of the system of FIG. 8.

FIGS. 10A-10E show schematic diagrams of embodiments of the system ofFIG. 8 at various possible stages of deployment during a procedure.

FIG. 11 is a section view of the proximal end of an embodiment of thesystem of FIG. 8 during introduction of the system into the body.

FIG. 12 is a side view of the distal end of an embodiment of the systemof FIG. 8 during introduction of the system into the body.

FIG. 13 is a section view of the proximal end of an embodiment of thesystem of FIG. 8 after deploying the curveable cannula into the body.

FIG. 14 is a side view of the distal end of an embodiment of the systemof FIG. 8 after deploying the curveable cannula into the body.

FIG. 15 is a section view of the proximal end of an embodiment of thesystem of FIG. 8 with the drive nut retracted.

FIG. 16 is a section view of the proximal end of an embodiment of thesystem of FIG. 8 after deploying the probe into the body.

FIG. 17 is a side view of the distal end of an embodiment of the systemof FIG. 8 after deploying the probe into the body.

FIGS. 18A and 18B are side views of the distal end of embodiments of thesystem of FIG. 8 with the curveable cannula in a stowed and deployedposition respectively.

FIG. 19A illustrates a perspective view of an embodiment of analternative system for generating a curved path in bone.

FIG. 19B illustrates the system of FIG. 19A in a deployed configuration.

FIG. 20 is a side view of system or kit having a slotted trocar forforming a path through bone.

FIG. 21 is a perspective view of an embodiment of the system of FIG. 20with stylets installed within the trocar and curved cannula.

FIG. 22 is a section view of an embodiment of the trocar of FIG. 20.

FIG. 23 is a top view of an embodiment of the trocar of FIG. 20.

FIGS. 24A through 24C show section views of embodiments of the trocar ofFIG. 20 with the curved cannula at different possible stages ofinsertion within the trocar.

FIG. 25 is a sectional view of an embodiment of the slotted curvedcannula of FIG. 20.

FIG. 26 is a top view of an embodiment of the slotted curved cannula ofFIG. 20

FIG. 27 is perspective view of an embodiment of a self-guiding curveabletreatment device.

FIG. 28 is a sectioned view of an embodiment of the curveable treatmentprobe of FIG. 27.

FIG. 29 is a sectioned view of an embodiment of the slotted trocar ofFIG. 27.

FIG. 30 is a top view of an embodiment of the slotted trocar of FIG. 27.

FIGS. 31A through 31C show section views of embodiments of the trocar ofFIG. 30 with the curveable treatment device at different possible stagesof insertion within the trocar.

FIG. 32 shows a perspective view of an embodiment of the distal end ofthe treatment device of FIG. 27 in a fully deployed state.

FIG. 33 shows a perspective view of the distal end of an embodiment ofthe curveable treatment probe of FIG. 27.

FIG. 34 illustrates a sectioned view of an embodiment of a vertebralbody with a path bored through the cortical shell.

FIGS. 35A-35C show embodiments of the self-guiding curveable treatmentdevice of FIG. 27 through various possible stages of deployment throughthe vertebral body.

FIGS. 36A-36D illustrate an embodiment of a steerable probe with aproximal handle having a thumb wheel.

FIGS. 37A-37C illustrate an embodiment of a steerable probe having aslotted hypotube.

FIGS. 38A-38C illustrate embodiments of a steerable probe proximalhandle having an ergonomic design and a thumb wheel.

FIGS. 39A-39D illustrate embodiments of a steerable probe proximalhandle with preset angles in a “stick shift” type configuration.

FIGS. 40A-40C illustrate embodiments of a steerable probe distal end andshow a distal end with a furled ceramic distal tip for guiding the probein a curved path in bone.

FIGS. 41A-41E illustrate embodiments of a steerable probe systemcomprising a steerable sleeve and a passively steered probe.

FIGS. 42A-42B illustrate an embodiment of a steerable probe systemcomprising a one-instrument design with a steerable inner probe and aretractable sleeve.

FIG. 42C illustrates an embodiment of a curved stylet.

DETAILED DESCRIPTION

Several embodiments of the invention are directed to systems and methodsto deploy and navigate a treatment instrument, such as a neuromodulationdevice (e.g., a radiofrequency (RF) bipolar energy delivery device, amicrowave energy delivery device, or a fluid or agent delivery device)within bone. Although the systems and methods described herein areprimarily directed to navigating through the bone of a vertebral memberof the spine, and particularly to treat the basivertebral nerve (BVN) ofa vertebral member, the treatment may be applied to any nerve and/or toany tissue segment of the body.

In accordance with several embodiments, the systems and methods oftreating back pain or facilitating neuromodulation of intraosseousnerves described herein can be performed without surgical resection,without general anesthesia, and/or with virtually no blood loss. In someembodiments, the systems and methods of treating back pain orfacilitating neuromodulation of intraosseous nerves described hereinfacilitate easy retreat if necessary. In accordance with severalembodiments of the invention, successful treatment can be performed inchallenging or difficult-to-access locations and access can be varieddepending on bone structure. One or more of these advantages also applyto treatment of tissue outside of the spine (e.g., other orthopedicapplications or other tissue).

FIGS. 1 and 2 illustrate an embodiment comprising a system or kit 10 forforming a path through bone. The system comprises a needle trocar 20(the main body of the instrument set). The trocar 20 comprises anelongate shaft 28 having a handle 24 at its proximal end 32 and a trocarchannel 36 passing through to the distal end 22 of the trocar 20. Thetrocar channel 36 is generally sized to allow the other instruments inthe system 10 to be slideably introduced into the patient to a treatmentregion. System 10 further comprises a straight stylet 80 having asharp-tipped needle 84 at its distal end that is used with the needletrocar 20 to create the initial path through the soft tissue andcortical shell to allow access to the cancellous bone, a curved cannula50 that is used to create/maintain the curved path within thebone/tissue. A straightening stylet 40 may be used to straighten out thecurve and load the curved cannula 50 into the needle trocar 20. A curvedstylet 60 may be used in conjunction with the curved cannula 50 tocreate the curved path within the bone/tissue, and a channeling stylet90 is used to create a working channel for a treatment device (such asRF probe 100) beyond the end of the curved path created by the curvedcannula 50.

The surgical devices and surgical systems described may be used todeliver numerous types of treatment devices to varying regions of thebody. Although embodiments of the devices and systems are particularlyuseful in navigating through bone, in one embodiment they may also beused to navigate through soft tissue, or through channels or lumens inthe body, particularly where one lumen may branch from another lumen.

The following examples illustrate embodiments of the system 10 appliedto generating a curved bone path in the vertebral body, and moreparticularly for creating a bone path via a transpedicular approach toaccess targeted regions in the spine. In particular, the system 10 maybe used to deliver a treatment device to treat or ablate intraosseousnerves, and in particular that basivertebral nerve. Although the systemand methods provide significant benefit in accessing the basivertebralnerve, in accordance with several embodiments, the system 10 maysimilarly be used to create a bone path in any part of the body (such asthe humerus, femur, pelvis, fibula, tibia, ulna, radius, etc.)

FIG. 3 illustrates a cross-sectional view of a vertebra 120. Recently,the existence of substantial intraosseous nerves 122 and nerve branches130 within human vertebral bodies (basivertebral nerves) has beenidentified. The basivertebral nerve 122 has at least one exit 142 pointat a location along the nerve 122 where the nerve 122 exits thevertebral body 126 into the vertebral foramen 132. Minimally invasiveinterventional treatments for lower back pain are a promisingalternative to existing non-surgical conservative therapy or spinalsurgery treatments, including spinal fusion. The basivertebral nerve mayprovide innervation to the trabecular bone of the vertebral body. Thebasivertebral nerves accompany the basivertebral vessels that enter thevertebrae through the large posterior neurovascular foramen. Thebasivertebral nerves may comprise segments having lengths between 5 and8 mm and diameters of 0.25 to 0.5 mm. The basivertebral nerve isbelieved to conduct pain receptive signals from intraosseous sources.Accordingly, modulation (e.g., defunctionalizati on, ablation) of thebasivertebral nerve is provided in several embodiments herein to reducechronic or acute back pain.

In accordance with several embodiments, the basivertebral nerves are at,or in close proximity to, the exit point 142. In some embodiments, theexit point 142 is the location along the basivertebral nerve where thebasivertebral nerve exits the vertebra. Thus, the target region of thebasivertebral nerve 122 is located within the cancellous portion 124 ofthe bone (i.e., to the interior of the outer cortical bone region 128),and proximal to the junction J of the basivertebral nerve 122 having aplurality of branches 130. Treatment in this target region isadvantageous because only a single portion of the basivertebral nerve122 need be effectively treated to modulate (e.g., denervate orotherwise affect the entire basivertebral nerve system). Treatment, inaccordance with one embodiment, can be effectuated by focusing in theregion of the vertebral body located between 60% (point A) and 90%(point B) of the distance between the anterior and posterior ends of thevertebral body. In some embodiments, treatment is located at orproximate (e.g., posterior to) the junction J. In some embodiments,treatment of the basivertebral nerve 122 in locations more downstreamthan the junction J requires the denervation of each branch 130. Thetarget region may be identified or determined by pre-operative imaging,such as from Mill or CT images. In various embodiments, treatment can beeffectuated by focusing in the region of the vertebral body located at aregion that is more than 1 cm from the outer cortical wall of thevertebral body, within a region that is centered at or about 50% of thedistance from the posterior outer wall of the vertebral body to theanterior outer wall, and/or within a region that is between 10% and 90%(e.g., between about 10% and about 60%, between about 20% and about 80%,between about 35% and about 65%, between about 5% and about 65%, betweenabout 10% and about 55%, or overlapping ranges thereof) of the distancefrom the posterior outer wall of the vertebral body to the anteriorouter wall.

In various embodiments, the junction J is located at a location of theterminus of the vertebral foramen, at the junction between a main trunkof the basivertebral nerve 122 and the initial downstream branches, at alocation corresponding to a junction between at least one of the initialdownstream branches and its respective sub-branches, or other locationsalong the basivertebral nerve 122.

In accordance with several embodiments, one approach for accessing thebasivertebral nerve involves penetrating the patient's skin with asurgical instrument, which is then used to access the desiredbasivertebral nerves, e.g., percutaneously. In one embodiment, atranspedicular approach is used for penetrating the vertebral cortex toaccess the basivertebral nerve 122. A passageway 140 is created betweenthe transverse process 134 and spinous process 136 through the pedicle138 into the cancellous bone region 124 of the vertebral body 126 toaccess a region at or near the base of the nerve 122. In one embodiment,a postereolateral approach (not shown) may also be used for accessingthe nerve. The transpedicular approach, postereolateral approach,basivertebral foramen approach, and other approaches are described inmore detail in U.S. Pat. No. 6,699,242, herein incorporated by referencein its entirety.

FIGS. 4A-4F illustrate an embodiment of a method for accessing thebasivertebral nerve with the system 10. First, the straight stylet 80can be inserted in aperture 26 at the proximal end 32 of needle trocar20. The straight stylet 80 can be advanced down the trocar channel 36(see FIG. 2) of the trocar 20 until the proximal stop 82 abuts againsthandle 24 of the trocar 20, at which point the distal tip 84 of straightstylet protrudes out of the distal end 22 of the trocar 20. In oneembodiment, the tip 84 of the straight stylet 80 comprises a sharp tipfor piercing soft tissue and bone.

Referring now to FIG. 4A, in some embodiments, the assembly (trocar 20and straight stylet 80) is advanced through soft tissue to the surfaceof the bone. Once the proper alignment is determined, the assembly canbe advanced through the cortical shell of pedicle 138 and into thecancellous interior 124 of the bone.

In some embodiments, after the proper depth is achieved, the straightstylet 80 is removed from the trocar 20, while the trocar 20 remainsstationary within the vertebra 120. The straightening stylet 40 can thenbe inserted into proximal aperture 52 (see FIG. 2) of the curved cannula50 and advanced along the central lumen of the curved cannula 50 untilthe stop 42 of the stylet 40 abuts up to the proximal end of the curvedcannula. In some embodiments, this advancement forces the distal tip ofthe straight stylet through the curved section 56 of the curved cannula50 to straighten out the curve 56. In some embodiments, the straightstylet comprises a hard, noncompliant material and the distal end 56 ofthe curved cannula 50 comprises a compliant, yet memory retainingmaterial (e.g. Nitinol, formed PEEK, etc.) such that the curved 56section yields to the rigidity of the straightening stylet 40 wheninstalled, yet retains its original curved shape when the stylet 40 isremoved.

As shown in FIG. 4B, once the straightening stylet 40 is secure and thecurved cannula 50 is straight, they can be inserted together into theneedle trocar 20 and secured. Proper alignment (e.g. prevent rotation,orient curve direction during deployment) may be maintained by aligninga flat on the upper portion 57 of the curved cannula 50 to an alignmentpin secured perpendicularly into the needle trocar 20 handle 24. Otheralignment elements may also be used (e.g., visual indicia such as lines,text, shapes, orientations, or coloring). In some embodiments, once thecurved cannula 50 is secure, the straightening stylet 40 is removed,while the curved cannula 50 remains stationary within the trocar 20.

Referring to FIG. 4C, in accordance with several embodiments, the curvedstylet 60 can then be straightened out by sliding the small tube 68proximally to distally on its shaft towards the distal tip 64 or fromthe distal tip 64 proximally on its shaft towards the proximal end 62.In some embodiments, once the curved distal tip 66 is straightened outand fully retracted inside the small tube 68, the curved stylet 60 maybe inserted into the proximal aperture 52 of the curved cannula 50,which still resides inside the needle trocar 20. As the curved stylet 60is advanced into the curved cannula 50, the small tube 68 may be met bya stop 55 (see FIG. 4C). As the curved stylet 60 continues to advance,the small tube 68 may be held inside the handle of the curved cannula50. This can allow the curve of the stylet 60 to be exposed inside thecurved cannula 50. To create the maximum force, the curve of the twoparts (50 & 60) may be aligned. To facilitate alignment, the cap on thecurved stylet 60 can have an alignment pin 70 which engages withalignment notch 52 on the proximal end of the curved cannula 50. Otheralignment elements may also be used (e.g., visual indicia such as lines,text, shapes, orientations, or coloring).

Once the stylet 60 is fully seated and aligned with the curved cannula50, the tip of the curved stylet 60 may protrude from the tip of thecurved cannula 50 by about 1/16 to 3/16 inches. This protrusion can helpto drive the curve in the direction of its orientation duringdeployment.

Referring now to FIG. 4D, in accordance with several embodiments, withthe curved stylet 60 and the curved cannula 50 engaged, the locking nut58 at the top of the curved cannula 50 may be rotated counter clockwiseto allow the cannula 50 and stylet 60 to be advanced with relation tothe needle trocar 20 such that the proximal end 52 rests or abutsagainst locking nut 58, advancing the curved cannula 50 and stylet 60beyond the distal opening of trocar 20 to generate a curved path in thecancellous bone region 124. As the curved cannula 50 and stylet 60 areadvanced they can curve at a radius of 0.4 to 1.0 inches throughcancellous bone and arc to an angle between approximately 0° toapproximately 180° (e.g., from approximately 5° to approximately 110°,from approximately 45° to approximately 110°, from approximately 15° toapproximately 145°, from approximately 30° to approximately 120°, fromapproximately 60° to approximately 90°, from approximately 10° toapproximately 45°, overlapping ranges thereof, or any angle within therecited ranges). Once the curved cannula 50 and stylet 60 are deployedto the intended angle, the locking nut at the top of the curved cannula50 may be engaged with the needle trocar 20 to stop any additionaladvancement of the curved stylet cannula assembly.

In accordance with several embodiments, FIGS. 7A-7B illustrate the tipof a curved stylet 60, which has been formed with two angles. To helpthe curve deployment in the proper direction, the curve 66 of the curvedstylet 60 may be shaped in a predetermined orientation. The angle on theinside of the curve 72 may be less than the angle on the outside of thecurve 74. This disparity in angles helps the stylet cannula assembly(collectively 50, 60) curve in the bone as bone pushes against outsidecurve face 74, thereby ensuring the curve radius is maintained duringdeployment, according to one embodiment.

Referring now to FIG. 4E, in accordance with several embodiments, thecurved stylet 60 may then be removed and replaced by the channelingstylet 90. The tip 94 of the channeling stylet 90 may be advanced beyondthe end 54 of the curved cannula 50 towards the intended targettreatment zone.

Referring now to FIG. 4F, in accordance with several embodiments, oncethe channeling stylet 90 reaches the target treatment zone, it isremoved, thereby creating a working channel. In some embodiments,channel 140 generally has a first section 142 that crosses the corticalbone of the pedicle 138, followed by a curved path. These sections maybe occupied by curved cannula 50 such that a treatment device fedthrough the cannula 50 will have to follow the curve of the cannula 50and not veer off in another direction. The channel 140 may furthercomprise the linear extension 146 in the cancellous bone 124 to furtheradvance the treatment device toward the treatment site T. In someembodiments, the treatment site T corresponds to a location of aterminus of the nerve 122 (e.g., terminus of the basivertebral foramenor the junction between a main trunk of the basivertebral nerve and itssub-branches). In some embodiments, the treatment site or location T isidentified without knowing the precise location of the basivertebralnerve 122.

With the trocar 20 and curved cannula 50 still in place, a treatmentdevice (e.g. treatment probe 100 shown in FIG. 2) with an active element102 on the distal end 104 of elongate flexible catheter 110 may bedelivered to the target treatment location T to perform a localizedtreatment. In some embodiments, the target treatment location T isidentified prior to introduction of the trocar 20 by magnetic resonance(MR) imaging, computed tomography (CT) imaging, or other imagingmodalities. The introduction of the trocar 20, curved cannula 50,treatment device, and/or other instruments can be visualized in realtime using fluoroscopic or other imaging to ensure proper introductionand orientation within the target treatment location. In accordance withseveral embodiments, the treatment (e.g., neuromodulation) can beperformed at multiple levels of vertebrae (simultaneously orsequentially with one, two, three or more treatment devices). The levelsmay be adjacent or spaced apart. For example, treatments can beperformed at the L4 and L5 levels, at the L3-L5 levels, at the L5 and Silevels, or at other combinations of lumbar, sacral, cervical or thoracicvertebral levels. In some embodiments, a single treatment system ordevice (e.g., a generator and one or more radio frequency probes withone or more electrode pairs) or multiple treatment systems or devices(e.g., two or more generators each with one, two, three or moreradiofrequency probes) are used to administer the treatment. In oneembodiment, multiple treatment probes can be daisy-chained or otherwisereversibly or integrally coupled to (or integral with) each other and/orto a single generator or other energy generation module tosimultaneously treat multiple levels of vertebrae that are spaced apart.A “y” shaped device may be used in some embodiments. In variousembodiments, the treatment devices comprise one, two, three or moreenergy sources (e.g., electrodes) that can be connected by one or moreconnection members or elements to space the energy sources apart tosimultaneously treat multiple levels of vertebrae. Simultaneoustreatment of two or more vertebrae may be treated with radiofrequency orother therapeutic modalities (ultrasound, radiation, steam, microwave,laser, cryoablation, etc.). Different therapeutic modalities ordifferent energy levels of the same therapeutic modality that worksimultaneously are provided in some embodiments.

In one embodiment, the active element 102 is delivered to the treatmentsite and activated to deliver therapeutic treatment energy. In variousembodiments, the treatment device comprises a probe, catheter, antenna,wire, tube, needle, cannula, sleeve, or conduit. The treatment devicemay comprise an RF delivery probe having bipolar electrodes 106 and 108that deliver a therapeutic level of heating (e.g., thermal dose) tomodulate (e.g., stimulate or ablate) at least a portion of the nerve122.

In some embodiments, the treatment device comprises a microwave energydelivery device comprising one or more antennas. In some embodiments,the treatment device comprises a chemical ablation or cryoablationdevice comprising a fluid conduit for delivery (e.g., injection) offluids, chemicals or agents (e.g., neurolytic agents) capable ofablating, stimulating, denervating, blocking, disrupting, or otherwisemodulating nerves. In some embodiments, the treatment device comprisesan ultrasound delivery device having one or more transducers or a laserenergy delivery device comprising one or more light delivery elements(e.g., lasers, such as fiber optic lasers or vertical cavity surfaceemitting lasers (VCSELs), or light emitting diodes (LEDs)).

According to several embodiments of the invention, many treatmentmodalities can be delivered to the treatment site for modulation ofnerves or other tissue (e.g., neuromodulation, ablation, temporary orpermanent denervation, stimulation, inhibition, blocking, disruption, ormonitoring). For example, treatment may be affected by monopolar ortripolar RF, ultrasound, radiation, steam, microwave, laser, or otherheating means. These modalities may be delivered to the treatment sitethrough one or more of the embodiments of systems and/or methodsdisclosed herein, and treatment applied such that the nerve is heated tothe desired level for the desired duration (e.g., a sufficient thermaldose is applied) to affect stimulation, denervation, ablation or thedesired therapeutic effect.

For example, the ultrasonic energy can be controlled by dosing, pulsingor frequency selection to achieve the desired heating level for thedesired duration. Similarly, microwave treatment may be applied using amicrowave energy delivery catheter and/or one or more antennas.Microwaves may be produced with a frequency in the range of 300 GHz to300 MHz, between 1 GHz and 5 GHz, between 2 GHz and 10 GHz, between 10GHZ and 100 GHz, 100 GHz and 300 GHz, between 50 GHz and 200 GHz,between 200 GHz and 300 GHz, or overlapping ranges thereof. Pulses ofbetween 1-5 seconds, between 2-3 seconds, between 0.5 seconds-2 seconds,between 4-5 seconds, between 5-10 seconds, between 10-30 seconds, oroverlapping ranges between, in duration may be generated. In someembodiments, a single pulse, 1-3 pulses, 2-4 pulses, 3-8 pulses, 8-20pulses, or overlapping ranges between, may be generated.

Radiation therapy may use radiation sources comprising any one of anumber of different types, such as, but not limited to, particle beam(proton beam therapy), cobalt-60 based (photon or gamma-ray source suchas that found in the GammaKnife), or linear accelerator based (e.g.,linac source). The dose of radiation delivered to the patient willtypically range between 10 Gy and 70 Gy. However, because the treatmentregion is contained within the large bony mass of the vertebral body,higher doses may be contemplated, as there is little risk to surroundingtissues that are more vulnerable. The dose may be varied based on thetreatment volume, or other variables such as treatment time and doseconcentration. A prescription of 35 instances of a 2 Gy dose might bereplaced by 15 instances of a 3 Gy dose, a technique known as“hypofractionation.” Taken to its logical extreme, this might bereplaced with a single 45 Gy dose if the dosage delivered to healthytissue can be reduced significantly. An identification dose may in someembodiments be used prior to the treatment dose, for example, to elicitsome response form the patient relating to the patient's pain. Theidentification dose is generally a much smaller dose than treatment doseTD, so as not to damage healthy tissue. Doses may range from 0.5 Gy to 5Gy. However, this range may also change based on considerations such asanatomy, patient, etc.

Additionally or alternatively, the treatment device may comprise a fluidor agent delivery catheter that deposits an agent or fluid, e.g. bonecement, phenol, alcohol, neurotoxin, inhibitory or stimulatory drug,chemical, or medicament, for neuroablation or permanent or temporarydenervation, or other therapeutic agent, to the treatment site orlocation T. Growth factors, stem cells, gene therapy or other biologicaltherapeutic agents may also be delivered.

In some embodiments, cryogenic cooling may be delivered for localizedtreatment of the basivertebral nerve or an intraosseous nerve using, forexample, liquid nitrogen, liquid nitrous oxide, liquid air, or argongas. Cryotherapy may be delivered in one or more freeze cycles. Inseveral embodiments, two freeze-thaw cycles are used. In someembodiments, 3-5 freeze-thaw cycles are used. In some embodiments, asingle freeze-thaw cycle is used In some embodiments, a desiredtemperature of the tissue is −40° C. to −50° C., −20° C. to −40° C.,−35° C. to −45° C., −50° C. to −80° C., or overlapping ranges thereof.The desired temperature may be maintained for 5-20 minutes, 10-15minutes, or greater than 10 minutes, depending on the temperature andthermal dose desired. Furthermore, treatment may be effected by anymechanical destruction and or removal means capable of severing ordenervating the basivertebral nerve. For example, a cutting blade, bur,electrocautery knife or mechanically actuated cutter may be used toeffect denervation of the basivertebral nerve.

In addition to or separate from treating (e.g., modulating) thebasivertebral nerve or an intraosseous nerve, a sensor may be deliveredto the region to preoperatively or postoperatively measure nerveconduction at the treatment region. In this configuration, the sensormay be delivered on a distal tip of a flexible probe that may or may nothave treatment elements as well.

In accordance with several embodiments, the goal of the treatment may beablation, or necrosis of the target nerve or tissue, or some lesserdegree of treatment to denervate the basivertebral nerve. For example,the treatment energy or frequency may be just sufficient to stimulatethe nerve to block the nerve from transmitting signals (e.g. signalsindicating pain) without ablation or necrosis of the nerve. Themodulation may be temporary or permanent.

In accordance with several embodiments, the therapeutic modalitiesdescribed herein (including energy or agent delivery) modulatesneurotransmission (e.g., neurotransmitter synthesis, release,degradation and/or receptor function, etc.). In some embodiments,signals of nociception are affected. Effects on neurokinin A,neuropeptide Y, substance P, serotonin and/or other signaling pathwaysare provided in some embodiments. Calcium and/or sodium channel effectsare provided in one embodiment. In some embodiments, G-protein coupledreceptors are affected.

Once the treatment is complete, the probe 100 may be withdrawn. Thecurved cannula 50 may then be withdrawn into the needle trocar 20. Theneedle trocar 20 with the curved cannula 50 may then be removed and theaccess site may be closed as prescribed by the physician or othermedical professional.

In the above system 10, in accordance with several embodiments, thedesign of the curves 56 and 66 of the curved cannula 50 and curvedstylet 60 is such that a flexible element (e.g., distal portion of thetreatment device) can navigate through the angular range of deploymentof the curved cannula 50 (e.g., Nitinol or other material tube). Thecurved cannula 50 allows the flexible element to navigate through acurve within bone without veering off towards an unintended direction.Cancellous bone density varies from person to person. Therefore,creating a curved channel within varying density cancellous bone 124will generally not predictably or accurately support and contain thetreatment device as it tries to navigate the curved channel.

With the system 10, the treatment device 100 may be deployed into thebone through the curved cannula 50 (e.g., Nitinol tube), which supportsthe flexible element (e.g., distal portion of the treatment device) asit traverses through the curve. When it departs from the tube, it willdo so in a linear direction along path 146 towards the target zone. Inaccordance with several embodiments, this advantageously allows the userto predictably and accurately deploy the treatment device towards thetarget zone or location T regardless of the density of the cancellousbone.

In some embodiments, a radius of curvature that is smaller than thatwhich can be achieved with a large diameter Nitinol tube may beadvantageous. To achieve this, the curved portion of the curved cannula50 may take one of several forms. In one embodiment, the curved cannula50 is formed from a rigid polymer (e.g., formed PEEK) that can be heatset in a particular curve. If the polymer was unable to hold the desiredcurve, an additional stylet (e.g. curved stylet 60) of Nitinol, flexiblestainless steel, shape memory material, metallic or metallic-basedmaterial, or other appropriate material, may also be used in conjunctionwith the polymer tube to achieve the desired curve. In some embodiments,the stylet comprises a braided tube, rod, or wire. In some embodiments,the stylet comprises a non-braided tube, rod, or wire, or combinationsthereof. This proposed combination of material may encompass any numberor variety of materials in multiple different diameters to achieve thedesired curve. These combinations only need to ensure that the finaloutside element (e.g. trocar 20) be “disengageable” from the internalelements and have an inner diameter sufficient to allow the desiredtreatment device 100 to pass to the treatment region T. In accordancewith several embodiments, the treatment region T is in a posteriorsection (e.g., posterior to a midline) of the vertebral body. Thetreatment region T may correspond to an expected location of a terminusof a basivertebral foramen.

In one embodiment, the curved cannula 50 may comprise a Nitinol, shapememory material, stainless steel or other metallic tube having a patternof reliefs or cuts (not shown) in the wall of the tube (particularly onthe outer radius of the bend). The pattern of cuts or reliefs couldallow the tube to bend into a radius tighter than a solid tube couldwithout compromising the integrity of the tubing wall. The curvedportion of the curved cannula 50 may comprise a different material thanthe main body of the curved cannula or the same material.

FIG. 5 illustrates a second embodiment of the system or kit 200 that maybe used to reduce the number of steps required for the procedure. Thesecond embodiment includes a needle trocar 20, straightening stylet 40,used with the needle trocar 20 and the curved cannula 50 to create theinitial path through the soft tissue and cortical shell to allow accessto the cancellous bone, curved stylet 60 used in conjunction with thecurved cannula 50 to create the curved path within the bone/tissue, andchanneling stylet 90 used to create a working channel for a treatmentdevice (e.g., probe) beyond the end of the curved path created by thecurved stylet.

In an embodiment of the method, the straightening stylet 40 is insertedinto the curved cannula 50 and secured. In this embodiment, thestraightening stylet 40 has a sharp tip 46 designed to penetrate bone.Once the straightening stylet 40 is secure and the curved cannula 50 isstraight, they are inserted into the needle trocar 20 and secured. Intone embodiment, the curved cannula 50 and straightening stylet 40 areinserted into the shaft 28 of the trocar 20 only as far as to have sharptip 46 of the straightening stylet 40 protrude from the distal end 22 ofthe trocar 20. Proper alignment is maintained by aligning a flat on theupper portion of the curved cannula 50 with a pin securedperpendicularly into the needle trocar 20 handle. Other alignmentelements may also be used (e.g., visual indicia such as lines, text,shapes, orientations, or coloring).

Referring now to FIG. 6, in accordance with several embodiments, oncethe curved cannula 50 is secure, the assembly (trocar 20, curved cannula50, and straightening stylet 40) may be advanced through soft tissue tothe surface of the bone. After finding the proper alignment at thepedicle 138 of vertebra 120, the assembly (trocar 20, curved cannula 50,and straightening stylet 40) may be advanced through the cortical shell128 and into the cancellous interior 124 of the bone.

In accordance with several embodiments, after the proper depth isachieved, the straightening stylet 40 may be removed. The curved stylet60 may then be straightened out by sliding the small tube 68 on itsshaft towards the distal tip 64. In some embodiments, the curved distaltip 66 is straightened out and fully retracted inside the small tube 68,and then the curved stylet 60 is inserted into the curved cannula 50,which still resides inside the needle trocar 20. Once the curved stylet60 is inserted into the curved cannula 50, the small tube 68 may be metby a stop 55 as illustrated in FIG. 4C. As the curved stylet 60continues to advance, the small tube 68 may be held inside the handle ofthe curved cannula 50. This can allow the curve of the stylet 60 to beexposed inside the curved cannula 50.

In several embodiments, to create a maximum force, the curves of the twoparts (50 & 60) may be aligned. To ensure alignment, the cap on thecurved stylet 60 may have an alignment pin, which engages with a notchon the top of the curved cannula 50. Other alignment elements may alsobe used (e.g., visual indicia such as lines, text, shapes, orientations,or coloring).

In one embodiment, when the stylet 60 is fully seated and aligned withthe curved cannula 50, the tip of the curved stylet 60 may protrude fromthe tip of the curved cannula 50 by about 1/16 to 3/16 inches. Thisprotrusion can help to drive the curved cannula 50 in the direction ofits orientation during deployment. Once the curved stylet 60 and thecurved cannula 50 are engaged, the lock nut at the top of the curvedcannula 50 may be rotated counter clockwise to allow the cannula 50 andstylet 60 to be advanced with relation to the needle trocar 20, asillustrated in FIG. 4D. As the curved cannula and stylet are advancedthey generate a curved path toward the treatment location T. Once thecurved cannula 50 and stylet 60 are deployed to the intended angle, thelock nut at the top of the curved cannula 50 may be engaged with theneedle trocar 20 to stop any additional advancement of the curved styletcannula assembly.

In accordance with several embodiments, the curved stylet 60 may then beremoved and replaced by the channeling stylet 90. In some embodiments,the channeling stylet 90 is advanced beyond the end of the curvedcannula 50, as illustrated in FIG. 4E, towards the intended targettreatment zone, thereby creating a working channel for the activeelement to be inserted. Once the channeling stylet 80 reaches the targettreatment zone, it can be removed and replaced by the treatment device100, which can be delivered to the treatment site T and activated.

Once the treatment is complete, the treatment device 100 can bewithdrawn. In some embodiments, the curved cannula 50 is then withdrawninto the needle trocar 20. The needle trocar 20 with the curved cannula50 can then be removed and the access site can be closed as prescribedby the physician or other medical professional.

In accordance with several embodiments, FIGS. 7A and 7B illustratedetailed views of a Nitinol or other shape memory material wire, rod ortube for the curved stylet 60 (proximal end not shown). The wirecomprises a shaft 78 having constant diameter D and a length L_(s) thatmay vary according to the application and desired depth to the treatmentlocation. The wire has a preformed distal tip that is curved to have aradius r that redirects the distal tip 64 at an angle θ with the shaft.As shown in FIG. 7A, angle θ is shown to be approximately 110°. Inaccordance with several embodiments, the preformed tip may have an angleranging from a few degrees (slight deflection off axis), to up to 180°(e.g. directing back toward the proximal end).

As shown in FIG. 7B detailing the distal tip 64, the tip may have adistal extension L_(T) that extends away from the shaft 78. To promotechanneling along a path that follows radius r, the distal tip 64 isconfigured with dual-plane bevels 74 and 72. Plane 74 is offset at angleβ, and plane 72 is offset at angle α. This configuration can allow forthe stylet and/or curved cannula to travel through bone in a pathcorrelating to the specified curve in the stylet and/or cannula.

In the example illustrated in FIGS. 7A and 7B, the curved stylet 60 mayhave a shaft length L_(S) of approximately 2-5 inches (e.g., 3.6 in.),diameter D of approximately 0.02-0.06 inches (e.g., 0.040 in.), and adistal tip length L_(T) of about 0.08-0.16 inches (e.g., 0.125 in.), aradius r of about 0.2-0.6 inches (e.g., 0.4 in.), and angle β=35° andangle α=31°. The angles may vary by up to about 10 degrees, up to 15degrees, or up to 20 degrees in either direction. It should be notedthat the above dimensions are for illustration only, and may varydepending on the anatomy and tissue type. For example, modulationdevices disclosed herein can be used, in some embodiments, to modulatenerves or treat tissue in other areas of the spine. Non-spinalapplications are also contemplated. For example, denervation of renalnerves, cardiac ablation and other non-spinal treatment can beaccomplished according to several embodiments described herein.

Any of the embodiments described herein may be provided as a kit ofinstruments to treat different regions of the body. For example, thelocation, orientation and angle of the treatment device with respect tothe trocar 20 may be varied by providing a set of instruments at varyingincrements. This may be achieved by varying the curvature (56, 66) inthe curved cannula 50 and curved stylet 60. The curvature may be variedby varying the radius of curvature r, the insertion depth (shaft lengthL_(S) and tip length L_(T), and/or the final exit angle θ with respectto the trocar 20 central bore. Thus, the physician or other clinicianmay select a different kit for treating a lumber spine segment asopposed to a cervical spine segment, as the anatomy will dictate thepath that needs to be channeled.

Thus in accordance with several embodiments, when treating differentspine segments, a set out of the kit may be selected to match thevertebra (or other region being treated). For example, delivering thetreatment device at or near the basivertebral nerve junction or terminusfor a lumbar vertebra may have a different angle than for a sacral orcervical vertebra, and may vary from patient to patient. The set may beselected from the kit intraoperatively, or from a pre-surgery diagnosticevaluation (e.g. radiographic imaging of the target region).

FIGS. 8-18B illustrate one embodiment of a system 201 for generating acurved path in bon. FIG. 8 shows a perspective view of system 201 in aconfiguration ready for deployment within a patient's body. System 201comprises an introducer/trocar 210 having a proximal end housing 202coupled to an elongate delivery tube 204. The distal end tip 208 has asharpened and/or beveled tip to facilitate entry into and deliverythrough at least a portion of a bony mass such as the vertebral body.The proximal end of the assembly (e.g., drive nut 270), may comprise ahard, rigid material to allow the trocar 210 to be tapped into placewith a mallet or the like.

The elongate delivery tube 204 comprises a laterally positioned radialopening or window 212 disposed just proximal or at the distal tip 208.The window 212 provides radial access from the central channel 218 oftube 204 so that an instrument or probe (e.g. probe 250 distal end) maybe delivered at an angle (e.g. non-axial) with respect to the tube axisor central channel 218.

FIG. 9 illustrates an exploded view of one embodiment of system 201prior to delivery within a patient. In one embodiment, the trocar 210 isintroduced to a location near the target treatment site as a wholeassembly shown in FIG. 8. In one embodiment, the trocar may also beintroduced to the location by itself, with the additional componentsbeing positioned once the trocar 210 is in place. In such aconfiguration, a stylet (not shown) may be positioned down the centralchannel 218 of the trocar 204 so as to block the aperture 212 from bonefragments or other tissue matter entering in channel 218. The stylet mayhave a hard, widened proximal end to allow the trocar 210 to be tappedinto place.

In one embodiment, the proximal end 206 of trocar housing 202 comprisesa centrally-located, counter-bore or recess 216 that is in communicationwith trocar channel 218. Trocar recess 216 allows placement andreciprocation of curveable cannula 230 within the trocar recess 216 andtrocar central channel 218. The curveable cannula 230 may be held inplace at a specified location within the trocar recess 216 via a stopnut 240 that is threaded about proximal body 246 of the curveablecannula 230. The curveable cannula 230 also comprises a central recess268 within proximal body 246 that is centrally aligned with cannulachannel 245. Central recess 268 and cannula channel 245 are configuredto receive and allow reciprocation of probe 250, which is threaded intodrive nut 270. In several embodiments, the drive nut 270 comprises ahardened proximal surface suitable for applying an impact force toadvance one or more of the trocar, curveable cannula, or probe throughbone.

FIGS. 10A-10E schematically illustrate one embodiment of system 201 invarious stages of deployment. 11, 13, 15 and 16 illustrate section viewsof the proximal end of one embodiment system 201 through the variousstages embodied in FIGS. 10A-10E. Correspondingly, FIGS. 12 and 14,illustrate close-up views of the distal end of one embodiment of system201 through various stages embodied in FIGS. 10A-10E.

FIG. 11 illustrates a sectional view of the proximal end of oneembodiment of system 201 in an un-deployed state prior to or duringinsertion of the trocar 210 to the desired treatment location in thepatient. For delivery into a vertebral body 120 (e.g. to access thebasivertebral nerve), the trocar 210 may be delivered through pedicle138 via channel 140 (as shown in FIG. 3). Channel 140 may be apre-drilled hole, or may be generated by insertion of the sharpened tip208 into the bone. To facilitate insertion, the proximal surface 292 ofcap 290 of the drive nut 270 may comprise a rigid material (e.g.stainless steel or the like) so that a mallet or similar device maystrike surface 292 to tap the trocar body 204 into place.

During insertion of the trocar 210, in accordance with severalembodiments, the stop nut 240 may be threaded distally along externalthreads 248 of the proximal body 246 of the curveable cannula 230 torestrict motion of the cannula 230 distally down trocar recess 216. Thisrestrained motion may keep the distal end 232 of the cannula 230 fromprematurely deploying while the trocar 210 is being delivered.

In accordance with several embodiments, the distal end of the curveablecannula is deformable so as to be delivered in a straight configurationthrough the trocar and deployed in a curved configuration outward fromthe radial opening at an angle with respect to the central axis. Asshown in FIG. 12, the distal tip 233 of the curveable cannula 230 maycomprise a series of tubular mating links 234 each having a central boreto provide a continuous cannula channel 245 along with cannula tube 244.The mating links 234 may be configured to cause the distal tip 233 ofthe curveable cannula to articulate into a curved shape and besteerable. Cannula channel 245 extends from central cannula recess 268of the proximal body 246 to the distal link 232 at tip 233. Distal link232 comprises a beveled tip 233 to facilitate the curveable cannula 230generating a path through bone as detailed below. Distal link 232 mayalso comprise a hard material (e.g. stainless steel, thermoplastic, orthe like) to provide a rigid leading edge for the curveable cannula 230.

In one embodiment, the mating links 234 are held together with a cord242 that runs from the proximal body 246 of the curveable cannula 230,and terminates at an aperture 236 in the distal link 232. In someembodiments, the distal end of cord 242 terminates at a ball 238 that isdisposed in a counter-bore, countersink, or like retaining surface ofthe aperture 236 to retain the cord within the distal link 232.

Referring now to FIG. 10B, in accordance with several embodiments, oncethe trocar 210 is in place, stop nut 240 is threaded proximally alongexternal threads 248 of the proximal end 246 of the curveable cannula230 to allow motion of the cannula 230 distally downward in recess 214.

In accordance with several embodiments, the proximal body 246 ofcurveable cannula 230 may then be deployed downward within trocar recess216, as shown in FIG. 13. As there may be resistance from the bony massof the vertebral body (or other bony mass), the cannula 230 may betapped downward by striking the proximal surface of cap 290 (e.g. with amallet or the like) while holding the trocar at housing 202. In severalembodiments, the motion of proximal body 246 pushes tube 244 distallywithin channel 218 of the trocar body 204. This motion forces theleading edge 232 and trailing mating links 234 out of the radial window212 in tube 204, as shown in FIG. 14. The distal end of opening orwindow 212 comprises a ramp 209 to facilitate the leading edge 232 outthe window 212 at the proper angle with respect to the trocar tube 204central axis, and without catching or getting stuck at the distal end ofthe trocar 210.

In some embodiments, a pull cord 242 is coupled to the distal tip of thecurveable cannula 230, the pull cord extending to the proximal end ofthe trocar 210. In addition to the ramp 209, the curved path of thedistal tip 233 is facilitated by tension provided by cord 242, whichforces the mating links 232, 234 to arch upon the applied tension. Thepull cord may be configured to apply a tensile force to the distal endof the curveable cannula to bias the curveable cannula into a curvedconfiguration. In some embodiments, the cord 242 is coupled tomale-threaded dial 212 (see FIG. 8) to act as a pull cord to apply saidtension. The dial 212 may be turned clockwise or counterclockwise withininternal-threaded arm 214 to increase or relieve the tension on the cord242, thereby providing steering of the distal tip 233 while thecurveable cannula 230 is advanced down trocar body 204 and out window212 (e.g. increased tension provides a sharper radius, decreased tensionprovides a more relaxed or no radius.) The tensile force applied to thedistal tip of the curveable cannula 230 may be controlled from theproximal end of the trocar to steer the curveable cannula 230 along adesired path.

In an alternative embodiment, cord 242 may comprise a memory materialsuch as a Nitinol wire that fastens the tube 244 and links 232, 234 in apreformed curved-shape. The cord 246 in this configuration stretches toallow the curveable cannula 230 to be delivered into and stowed in alinear form within channel 218, and retracts when not restrained inchannel 218 to drive a curved path when exiting window 212.

As shown in FIGS. 13 and 14, in accordance with several embodiments, thecurveable cannula 230 is fully deployed, with the proximal end 246disposed at the bottom of recess 216, and the distal tip 233 in adeployed orientation forming a curved path (along with trailing links234) through the bone at the treatment site. In this configuration, theprobe 250 is restrained from axial motion (in the distal direction) withrespect to the curved cannula 230, because it is threaded inside athreaded recess portion of drive nut 270, which is restrained fromdistal motion by stop 258 in the proximal end 246.

As shown in FIG. 15, in accordance with several embodiments, the drivenut 270 may be raised (proximally advanced out of cavity 268) withrespect to the curveable cannula 230 and probe proximal body 254 byrotating the drive nut 270. The proximal body 254 of the probe 250comprises a male thread 256 that mates with the female internal threads262 in a distal recess of the drive nut 270. The thread pattern 256/262may be opposite of the thread pattern between the stop nut 240 andproximal end 246 of the curveable cannula 230 (e.g. right-handed threadvs. left-handed thread), so that rotation of the drive nut 270 does notresult in rotation of the curveable cannula 230.

Furthermore, the proximal end 254 of the probe 250 may comprise aplurality of vertical grooves 264, at least one of which interfaces withkey 266 of the curveable cannula 230. This interface, in one embodiment,only allows axial motion of the proximal body 264 with the curveablecannula 230, and restricts rotation of the proximal body 264 with thecurveable cannula 230. Thus, rotation of the drive nut 270 may onlyresult in proximal translation of the drive nut 270. As seen in FIG. 15,the probe proximal body 254 is now free to move downward in cavity 268.

Referring now to FIGS. 16 and 17, in accordance with severalembodiments, the system 201 is shown in a fully deployed state, with thedistal shaft of the probe 250 advanced beyond distal end 233 of thecurveable cannula central channel 245. In several embodiments, thisdeployment is achieved by advancing the proximal body 254 within thecavity 268 of the curveable cannula 230. In several embodiments, theproximal body 254 and drive nut 270 are advanced as a unit within cavity268 in accordance with several embodiments, (e.g., by tapping the cap290), thereby providing an impact force to advance the probe tip 274 outof the cannula 230 and through tissue and/or bone to reach the desiredtreatment or diagnostic location within the body.

In one embodiment, a channeling stylet (such as stylet 90 shown in kit10 of FIG. 1) may also be used to create a working channel beyond theend of the curved path created by the curveable cannula 230 prior todeploying a probe for treatment or diagnostic purposes.

Once the distal tip 274 of the probe 250 is positioned at the desiredlocation, treatment of the target tissue may be performed. As shown inFIG. 17, probe distal end 274 may comprise a first electrode 274configured to deliver a therapeutic amount of RF energy to the targetlocation. In the configuration shown in FIG. 17, the probe 250 comprisesa bipolar probe with a return electrode 276, in accordance with severalvarious embodiments, the probe 250 comprises any treatment instrument ordevice described herein.

Cap 290 may further be configured to include (e.g. a self-containedunit) a power source (e.g. battery) and receptacles (not shown) tocouple to the probe 250, thereby supplying the energy to deliver atherapeutic level of energy to the tissue. In this configuration, thecap 290 may have sufficient power to deliver one or more metered dosesof energy specifically measured to modulate (e.g., denervate) at least aportion of the basivertebral nerve of a vertebral body.

In accordance with several embodiments, the cap 290 may be threaded (orotherwise releasable coupled) into drive nut 270 to be interchangeabledepending on the application or step of the procedure. For example, acap 290 having a reinforced/hardened surface 292 used for driving thesystem 201 into the bone may be replaced by another cap having couplings(not shown) for probe 250, an internal power supply (not shown), orcouplings for an external power supply/controller (not shown) fordelivering energy for treatment and/or diagnosis of a region of tissue.For embodiments wherein a fluid and/or agent is delivered to the targettissue, the cap 290 may be configured to facilitate delivery of thefluid through a probe having one or more fluid delivery channels. Insome embodiments, the interchangeable cap 290 is configured to provideaccess to the probe 250 for providing a therapeutic energy.

FIGS. 18A and 18B are side views one embodiment of the distal end of thesystem 201 with the curveable cannula 230 in a stowed and deployedposition respectively. The distal link 232 and trailing links 234 areconfigured to have mating/interlocking surfaces that allow the distalend of the cannula to curve in one direction. The more distal link of amating pair will have an extension 235 that mates with a corresponddepression 237 in the link proximal to it. This allows the links torotate with respect to each other to create a curved distal end as shownin FIG. 18B.

FIGS. 19A and 19B illustrate an alternative embodiment of system 300 forgenerating a curved channel through bone. System 300 comprises a tubulartrocar body 302, the proximal end (not shown) of which may comprise aportion or all of any of the previously described proximal ends fordevices 10, 200, or 201 disclosed herein. The distal tip 334 comprises aleading edge surface for advancing through bone, and a radial or lateralwindow 304 allowing access to the central channel of the trocar body302. The window 304 is positioned a short distance proximal to thedistal tip 334.

In one embodiment, a curveable cannula 322 is positioned in the trocar302, the curveable cannula 322 having a distal end 324 coupled vialinkage 326 to a pivotable arm 310. The proximal end (not shown) of thecurveable cannula may comprise a portion or all of any of the previouslydescribed proximal ends for devices 10, 200, or 201 disclosed herein.The pivotable arm 310 has a first end pivotably coupled at joint 314 ata location at or near the distal tip 334 of the trocar 334. In a stowedconfiguration (illustrated in FIG. 19A), the pivotable arm is configuredto lay axially in the trocar 302 within slot 306 that runs from pivot314 proximally to the radial opening or window 304. The proximal (whenstowed) end 312 of the arm 310 is coupled to the linkage 326.

As shown in FIG. 19B, in accordance with several embodiments, thecannula 322 may be advanced laterally outward from window 304 by simplyadvancing the cannula 322 distally down the trocar 302. The pivotablearm 310 constrains the motion of the curveable end 320 of the cannula toa curved path of specified radius (determined by the length of arm 310.Once the pivotable arm has reached full rotation (shown approximately 90degrees in FIG. 19B, however such angle may be specified to be anydesired amount), the cannula end 320 has created a curved path outwardfrom the trocar toward the desired treatment site. A probe, stylet orsimilar device (such as curved stylet 60, channeling stylet 90, or probe100 of FIG. 1) may be positioned at the opening of the distal end 320 tofacilitate generating the curved bore without allowing tissue or bone toenter the cannula. The probe or treatment and/or diagnostic device maythen be routed through the cannula end 320 to a region of tissue or bonethat is off-axis from the trocar body 302.

FIGS. 20 through 26 illustrate several embodiments of the inventioncomprising a system or kit 400 for forming a path through bone. Thesystem 400 comprises a slotted needle trocar 410 (e.g., the main body ofthe instrument set) that functions as an introducer into a vertebralbody. The slotted needle trocar 410 comprises an elongate shaft 414having a slotted handle 412 at its proximal end and a trocar channel 418passing through to the distal end 416 of the trocar 410. The trocarchannel 418 is generally sized to allow the other instruments in thesystem 400 (e.g. curved cannula, therapy device, etc.) to be slideablyintroduced into a patient to a desired treatment region (e.g., avertebral body identified as a source of back pain).

In one embodiment, system 400 further comprises a straight stylet 450having an elongate shaft 454 configured to be received in trocar channel418 of slotted needle trocar 410. Elongate shaft 454 has a sharp-tippeddistal end 456 that, when installed fully within the slotted needletrocar 410, extends slightly beyond the distal end 416 of the trocartube 410 (see FIG. 21) to close opening 418 and provide a leading edgeto create the initial path through the soft tissue and cortical shell,thereby allowing access to the cancellous bone of the vertebral body.

In one embodiment, cannula stylet 450 comprises a pair of keyprotrusions 458 that are orthogonally oriented with respect to thelength of the stylet handle 452. The key protrusions are configured tolock with key slots 426 on the trocar handle 412 via rotation of thestylet handle 452 after full insertion in the trocar 410. When thestylet handle 452 is fully rotated to the orientation shown in FIG. 21,the key protrusions 458 lock the stylet 450 from linear motion withrespect to the trocar 410.

With the stylet 450 locked into place with respect to the trocar handle412, the stylet 450 and slotted needle trocar 410 may be configured tobe inserted in unison into the patient's tissue. In accordance withseveral embodiments, this step may be performed prior to insertion intothe patient or after insertion into the patient.

In one embodiment, the stylet handle 452 comprises a raised strikingsurface 460 made of a hard, rigid material (e.g. stainless steel orsimilar metallic or plastic material) to allow the trocar 410 to betapped into place with a mallet or the like, particularly when piercingthe hard cortical shell of the vertebral body.

In accordance with several embodiments, FIGS. 20 and 21 illustrateexploded views of system 400 prior to delivery within a patient. FIG. 22illustrates a sectional view of the proximal end of slotted needletrocar 410 in an un-deployed state prior to or during insertion of thetrocar 410 to the desired treatment location in the patient. Fordelivery into a vertebral body 120 (e.g., to access a basivertebralnerve), the slotted needle trocar 410 may be delivered through pedicle138 via channel 140 (as shown in FIG. 3). Channel 140 may be apre-drilled hole, or may be generated by insertion of the sharpened tip208 into the bone. To facilitate insertion, the striking surface 460 ofstylet 450 may be tapped with a mallet or the like to drive the slottedneedle trocar 410 into place.

In one embodiment, system 400 further comprises a curved cannula 430that is used to create and/or maintain a curved path within the boneand/or tissue when extended past the distal end 416 of trocar 410.Curved cannula 430 may comprise a slotted handle 432 that is proximal toa threaded tube 446 and elongate straight tubular body 434 section and apreformed, curved distal end 436. In accordance with severalembodiments, the curved distal end 436 of tubular body 434 is made of ashape memory material (e.g., Nitinol) that allows the curved distal endto be bent into a straight configuration, and retain its curved shapeupon release of a restraint.

Referring to FIGS. 22 and 23, in accordance with several embodiments,the handle 412 of slotted needle trocar 410 comprises acentrally-located bore or recess 420 that is in communication withtrocar channel 418. Trocar recess 420 allows placement and movement ofcurved cannula 430 within the trocar recess 420 and trocar channel 418.The trocar recess 420 may have a tapered section 428 at the bottom ofhandle 412 so that no sharp edges are present to hang up instrumentsentering central channel 418 to catch or hang up on. In communicationwith the trocar recess 420 is a lateral slot 422 running through thehandle 412 generally orthogonally or radially to the axis of the trocarrecess 420 and central channel 418. The lateral slot 422 may have acurvilinear lower surface 424 that is configured to allow the curveddistal end 436 of the curved cannula 430 to be inserted in the trocar410 without having to pre-straighten the curved cannula 430.

In one embodiment, the curved cannula 430 is held in place at aspecified location within the trocar recess 420 and trocar channel 418via a stop nut 440 that is threaded about proximal body 446 of thecurved cannula 430. With the stop nut 440 in the position shown in FIG.20, the distal end 436 of the curved cannula 430 can be restrained frommoving past opening 418 at distal end 416 of the slotted needle trocar410. When the curved cannula 430 is prepared for delivery beyond thedistal end 416 of the slotted needle trocar 410 (e.g., afterinstallation of curved stylet 470 is complete), the stop nut can berotated up threaded body 446 to allow downward motion of the curvedcannula 430 within the slotted needle trocar 410. Stop 442 and key 444interface with the trocar 410 to help ensure the trajectory of thecurved distal end 436 is correctly oriented.

In accordance with several embodiments, FIGS. 24A through 24C illustrateinsertion of the curved cannula distal end 436 into the slotted needletrocar 410. In accordance with several embodiments, this step isperformed after the trocar 410 has been positioned at the properlocation within the vertebral body (e.g. as shown in FIG. 3 to generatepassageway 140 between the transverse process 134 and the spinousprocess 136 through the pedicle 138 into the cancellous bone region 124of the vertebral body 126). With the trocar 410 in position, thestraight stylet 450 may be removed to open the central channel 418 foradditional instrumentation.

As shown in FIG. 24A, in one embodiment, the curved distal end 436 ofthe curved cannula body 434 is inserted laterally into the lateral slot422 until it contacts the far wall of trocar recess 420 and thecurvilinear bottom surface 424 of the lateral slot 422. The lateral slot422 and curvilinear bottom surface 424 may advantageously allow thecannula 430 to be installed at an angle with respect to the centralchannel 418 (e.g., the straight portion 434 of the cannula 430 isinserted orthogonal, or substantially off-axis, from the axis of thetrocar channel 418), which allows a significant portion of the curveddistal end 436 to enter tapered region 428 and trocar channel 418 priorto contacting the trocar channel 418).

In one embodiment, the curvilinear bottom surface 424 comprises a radiussubstantially matching the natural radius of curved distal end 436. Thecurvilinear bottom surface 424 having such a matching radius mayadvantageously promote an evenly distributed loading along the curveddistal end 436 while the curved distal end 436 is advanced into thetapered section 428 and straightened into trocar channel 418.

In order to ensure proper trajectory of the curved cannula 430, theindicia arrows 404 of the curved cannula handle 432 (see FIG. 26) may belined up in the same direction as corresponding indicia arrows 402 onthe trocar handle 412. In some embodiments, other indicia may be used(e.g., slots, lines, notches, ribs, or laser markings).

Referring now to FIG. 24B, in accordance with several embodiments, aninward and/or downward force is applied on the curved cannula 430 toadvance the curved distal end 436 and tube body 434 into the trocarrecess 420 and central channel 418, which straightens the curved cannula430 to a more vertical orientation.

Referring to FIG. 24C, in one embodiment, the cannula tube body 434 isin a substantially vertical orientation once the entirety of the curvedend 436 is disposed within the central channel 418 (and thus deflectedto a substantially straight configuration). Further downward force maybe applied to the curved cannula 430 until the stop nut 440 reaches thetop of the trocar handle 412. The key protrusion 444 below the stop nut440 may further acts to guide the proper orientation of the curvedcannula 430 as it is restrained to travel linearly down lateral slot422.

Referring to FIGS. 25 and 26, the curved stylet 470 may then beinstalled into the curved cannula 430. The curved stylet 470 comprises astraight proximal stylet body 474 and a curved distal end 476. Inaccordance with several embodiments, the curved stylet 470 comprises apreformed, deformable memory material that, when installed in the curvedcannula 430, provides additional rigidity and inertia to the curveddistal end 426 of the cannula 430. In some embodiments, the curvedstylet 470 also provides a leading edge for the curved cannula 430 as itgenerates a curved path beyond the distal end 416 of the trocar.

In one embodiment, the curved cannula 430 comprises a central recess 448within cannula handle 432 that is in communication with and centrallyaligned with cannula channel 438. Central recess 448 and cannula channel438 may be configured to receive and allow reciprocation of curvedstylet 470 (and a treatment probe that may be deployed subsequently).Similar to the trocar handle 412, the cannula handle 432 may comprise alateral slot 433 that is in communication with the central recess 448.In one embodiment, lateral slot 433 comprises a curved lower surface 435that facilitates insertion of the curved tip 476 of the stylet body 474into the central recess 448 and cannula channel 438 (e.g., similar tothe illustration in FIGS. 24A-24C showing insertion of the curvedcannula 430 into the trocar 410). In one embodiment, the curvilinearbottom surface 435 of the cannula handle 432 comprises a radiussubstantially matching the radius of the preformed curved distal end 476of the curved stylet 470.

In accordance with several embodiments, to facilitate proper orientationof the curved end 476 of stylet 450 with the curved distal end 436 ofthe curved cannula 430, arrow indicia 406 (see FIG. 21) are disposed onthe curved stylet handle 472 to provide visualization of orientationwith respect to the arrow indicia 404 of the curved cannula 430. In someembodiments, other indicia may be used (e.g., slots, lines, notches,ribs, or laser markings). In one embodiment, key tab 478 limits fullextension of the curved stylet 470 into the curved cannula 430 unlesslined up with the slot 433.

With the curved stylet 470 installed into the curved cannula 430, thelock nut 440 may be raised along proximal body 446 of curved cannula430, and the curved stylet 470 and curved cannula 430 assembly may befurther extended down trocar central channel 418 so that the curveddistal end 476 generates a curved path beyond the distal end 416 of thetrocar 410.

In accordance with several embodiments, when the curved path is created,the curved stylet 470 is removed. A treatment probe (such as thetreatment probes described herein) may then be delivered through thecurved cannula 430 to the treatment site.

In some embodiments, a channeling stylet 490 is used to create a workingchannel beyond the end of the curved path created by the curveablecannula 430 prior to deploying a treatment probe for a diagnosticdevice. In one embodiment, the elongate body 494 of the channelingstylet 490 is inserted in the recess 448 of the cannula handle 432 anddelivered through the cannula channel 438 so that the distal end 496 ofthe channeling stylet 490 extends beyond the curved distal end 436 ofthe curved cannula 430 a specified distance, creating a hybrid curvedand straight channel through the cancellous bone. The channeling stylet490 may then be removed, and a treatment probe may be installed in itsplace to deliver therapeutic treatment to the target treatment site.

Several embodiments of the invention are shown in FIG. 27 through FIG.35C. In accordance with several embodiments, the apparatus may vary asto configuration and as to details of the parts, and the method may varyas to the specific steps and sequence, without departing from the basicconcepts as disclosed herein.

In accordance with several embodiments, surgical devices and surgicalsystems described herein may be used to deliver numerous types oftreatment modalities to varying regions of the body. In addition to theparticular usefulness of several embodiments in navigating through bone.The systems and methods may also be used to navigate through softtissue, or through channels or lumens in the body, particularly whereone lumen may branch from another lumen.

The following examples illustrate several embodiments of a system 510for generating a curve bone path in the vertebral body, and moreparticularly, for creating a bone path via a transpedicular approach toaccess targeted regions in the spine. In particular, the system 510 maybe used to deliver a treatment device to treat or modulate (e.g.,ablate) intraosseous nerves, and in particular the basivertebral nerve.In accordance with several embodiments, in addition to the system andmethods providing significant benefit in accessing the basivertebralnerve, the systems and methods may similarly be used to create a bonepath in any part of the body.

Referring to FIG. 27, one embodiment of the system 510 comprises aslotted needle trocar 520 (the main body of the instrument set) thatfunctions as an introducer into the vertebral body. The slotted needletrocar 520 comprises an elongate shaft or hypotube 524 having a slottedhandle 522 at its proximal end and a trocar channel 528 passing throughto the distal end 526 of the trocar 520. The trocar channel 528 maygenerally be sized to allow the elongate body 558 of a curved probe 550to be slideably introduced into a patient to a desired treatment region.

FIG. 28 shows a cross-sectional view of one embodiment of the proximalend of the treatment probe 550, which comprises a handle 552 having astriking surface 554, a radio frequency generator (RFG) cable connection556, and a dual-lead flex conduit 572 having a proximal end 570 couplingthe RFG cable connection 556 to one or more electrodes 554 via a slot574 in a stylet 558, which may be coupled to striking surface 554 atproximal end 576. The stylet 558 comprises a straight proximal end 576,and curved distal end 560. In one embodiment, RFG cable connection 556may be configured for coupling a power source to power operation ofelectrodes 554. In accordance with several embodiments, other couplingsmay be used for connecting cables to the device.

Referring to FIGS. 29 and 30, one embodiment of the handle 522 ofslotted needle trocar 520 comprises a centrally-located bore or recess534 that is in communication with trocar channel 528. Trocar recess 534facilitates placement and reciprocation of treatment probe 550 withinthe trocar recess 534 and trocar central channel 528. The trocar recess534 tapers at the bottom of handle 536 (e.g., so that no sharp edges arepresent to hang up instruments entering trocar channel 528).

In one embodiment, in communication with the trocar recess 534 is alateral slot 530 running through the handle 522 generally orthogonallyto the axis of the trocar recess 534 and trocar channel 528. The lateralslot comprises a curvilinear lower surface 532 that may be configured toallow the curved distal end 560 of the treatment probe 550 to beinserted in the trocar 520 without having to pre-straighten the curveddistal end 560 of the treatment probe 550. Indicia 540 may be positionedon the top of the handle 522 to guide proper orientation of thetreatment probe 550.

In accordance with several embodiments, FIGS. 31A through 31C illustrateinsertion of the curved distal end 560 of treatment probe 550 into thetrocar 520. In accordance with several embodiments, this step isperformed after the trocar 520 has been positioned at the properlocation within the vertebral body (e.g., as shown in FIGS. 59A and 59Bto pierce the cortical shell and generate passageway 640 in the vertebra620).

As shown in FIG. 31A, in accordance with several embodiments, the curveddistal end 560 of the treatment probe 550 is inserted laterally into thelateral slot 530 until it contacts the far wall of recess 534 and thecurvilinear bottom surface 532 of the slot 530. The slot 530 andcurvilinear bottom surface 532 allow the stylet 558 to be installed atan angle with respect to the trocar channel 528 (e.g., the straightportion 574 of the stylet 558 is inserted orthogonal, or substantiallyoff-axis, from the axis of the trocar channel 528), which may allow forthe tip 562 and a significant portion of the curved distal end 560 oftreatment probe 550 to enter trocar channel 528 prior to contacting thewalls of trocar channel 528).

In one embodiment, the curvilinear bottom surface 532 may comprise aradius significantly matching the natural radius of curved distal end560 of the treatment probe 560. The curvilinear bottom surface 532having such a matching radius may advantageously promote an evenlydistributed loading along the curved distal end 650 while the curveddistal end 560 is advanced into and straightened into trocar channel528.

To ensure proper trajectory of the probe 550 in one embodiment, theindicia arrows (not shown) of the probe handle 552 may be lined up inthe same direction as indicia arrows 540 (FIG. 30) on the trocar handle522. In some embodiments, other indicia may be used (e.g., slots, lines,notches, ribs, or laser markings, or combinations thereof).

Referring now to FIG. 31B, in accordance with several embodiments, aninward and/or downward force is applied on the probe 550 to advance thestylet 558 into the recess 534 and trocar channel 528, which straightensthe curved end 560 of stylet 558 to a more vertical orientation.

Referring to FIG. 31C, in accordance with several embodiments, thestylet 558 is in a substantially vertical orientation once the entiretyof the curved end 560 is disposed within the trocar channel 528 (andthus deflected to a substantially straight configuration). Furtherdownward force may be applied to the treatment probe 550 until thedistal tip reaches the end 526 of tube 524.

FIG. 32 shows a perspective view of one embodiment of the distal end ofthe treatment probe 550 in a fully deployed state. Stylet 558 comprisesa preformed curved distal end 560 having a beveled or sharpened distaltip 562. In accordance with several embodiments, stylet 558, and inparticular distal end 560, comprise a compliant, yet memory retainingmaterial such as memory metal (e.g., Nitinol), or polymer (e.g. PEEK,DELRIN, NYLON, VALOX, etc.), or a combination of both (e.g., Nitinolcore inside thermoplastic exterior), such that the curved distal end 560yields to the rigidity of the inner walls of trocar channel 528 wheninstalled, yet retains its original curved shape when the curved end 560of stylet 558 is removed from, or outside of, the trocar 520.

The distal end 560 of stylet 558 may be pre-curved to create an angularrange of approximately 0° to approximately 180° (e.g., fromapproximately 45° to approximately 110°, or from approximately 75° toapproximately 100°), when fully deployed from the trocar 520.

In several embodiments, the curved distal end 560 comprises a pluralityof circumferentially relieved sections 578 separated by a plurality ofbosses 566. The bosses 566 have an outside diameter that correspondsclosely to the inside diameter of the trocar channel 528 of hypotube 524(e.g., the diameter of each boss 566 will be approximately 0.025″ to0.060″ smaller than the diameter of the trocar channel 528). Thecircumferentially relieved sections 578 may allow for the curved distalend 560 to conform to the straight confines of the trocar channel 528,while promoting retention of the curved distal end 560 to its preformedcurved state. In one embodiment, the stylet 552 is machined with groove574 and recesses 578, 582 prior to heat setting the curve 560.

FIG. 33 shows a close-up view of one embodiment of the distal end 560 ofthe curveable treatment probe 550. Channel or slot 574 extends distallyon stylet 558 to house flex circuit 572 along the length of the stylet558. The curved distal end 560 of stylet 558 comprises a pair ofrecesses 582 configured to house a pair of electrodes 564 (e.g., tubularelectrodes) flush to the diameter of bosses 566 on either side of grove580. An insulation layer (not shown) may be disposed between the firstand second electrodes 564 and the stylet 552. The dual lead flex circuit572 is electrically coupled to each electrode 564 for application as abipolar RF applicator. The electrodes 564 may also be coated (e.g., withparylene, etc.) for insulation. In some embodiments the electrodes maybe of a different type or shape (e.g., elliptical or flat).

FIG. 34 illustrates a cross-sectional view of a vertebra 620. Theexistence of substantial intraosseous nerves 622 (e.g., basivertebralnerves), and nerve branches 630 within human vertebral bodies has beenidentified. The basivertebral nerve 622 has at least one exit 642 pointat a location along the nerve 622 where the nerve 622 exits thevertebral body 626 into the vertebral foramen 632.

In accordance with several embodiments, the basivertebral nerves are at,or in close proximity to, the exit point 642. Thus, the target region ofthe basivertebral nerve 622 is located within the cancellous portion 624of the bone (i.e., to the interior of the outer cortical bone region628), and proximal to the junction J of the basivertebral nerve 622having a plurality of branches 630 (e.g. between points A and B alongnerve 622). Treatment in this region may be advantageous because only asingle portion of the basivertebral nerve 622 need be effectivelytreated to denervate or affect the entire system. Typically, treatmentin accordance with this embodiment can be effectuated by focusing in theregion of the vertebral body located between 60%, 643, and 90%, 644, ofthe distance between the anterior and posterior ends of the vertebralbody. In contrast, treatment of the basivertebral nerve 622 in locationsmore downstream than the junction J may require the denervation of eachbranch 630.

In accordance with several embodiments for accessing the basivertebralnerve, the patient's skin is penetrated with a surgical instrument whichis then used to access the desired basivertebral nerves, i.e.,percutaneously. In one embodiment, a transpedicular approach is used forpenetrating the vertebral cortex to access the basivertebral nerve 622.A passageway 640 is created between the transverse process 634 andspinous process 636 through the pedicle 638 into the cancellous boneregion 124 of the vertebral body 626 to access a region at or near thebase of the nerve 622. It is appreciated that a postereolateral approach(not shown) may also be used for accessing the nerve.

In accordance with several embodiments, FIGS. 35A-C illustrate a methodfor accessing the vertebral cortex and treating the basivertebral nerveof a vertebra with the system 10 in accordance with several embodimentsof invention.

As shown in FIG. 35A, a straight stylet 650 may be inserted intoproximal recess 534 of trocar 520 and advanced such that sharpened tip654 of the stylet body 652 protrudes from the trocar distal end 56. Thestraight stylet 650 may have protrusions 658 just below stylet handle556 for locking the stylet 650 to the trocar handle 522. When the stylet650 is fully seated within trocar 520, the tip 654 of the straightstylet 650 may protrude from the distal end 526 of the trocar 220 (e.g.,by about 1/16 to 3/16 inches). The protrusion or tip 654 may help todrive the trocar 520 through the cortical shell 628 in the direction ofthe cancellous bone 624 of vertebral body 626.

Referring now to FIG. 35B, the trocar 520 and stylet 650 may be advancedinto the desired location within the vertebral body 626. The stylet 650comprises a striking surface 660 to drive the trocar 510 into thevertebra 620 by piercing the cortical shell 628 and generating straightpassageway 640 between the transverse process 634 and spinous process636 through the pedicle 638 into the cancellous bone region 624 of thevertebral body 626. With the trocar 520 in position, the straight stylet650 may be removed to open the trocar channel 528 for delivery ofadditional instrumentation.

In an alternative embodiment, the tip 562 of probe may be used as thestylet for piercing the cortical shell 628 and generating path 640through vertebra 620. In this configuration, the probe tip 662 is onlyadvanced slightly from distal end 526 of trocar hypotube 524 to act asstylet for advancement of trocar. A releasable collar (not shown) may beused between probe handle 552 and trocar handle 522 to restrictadvancement of the curved distal end 560 past distal opening 526 of thetrocar body 524. In one embodiment the trocar 520 is then driven to theproper location within the vertebral body 626 with striking surface 554to generate passageway 640 between the transverse process 634 andspinous process 636 through the pedicle 638 into the cancellous boneregion 624 of the vertebral body 626.

Referring now to FIG. 35C, with the trocar 510 in place, the treatmentprobe 550 may be advanced along the trocar channel 528 such that thecurved distal end 560 exiting the distal opening 526 generates a curvedpath 670 through the cancellous bone 624.

In accordance with several embodiments, treatment energy may then bedelivered via bipolar electrodes 564 to the target treatment location Tat the basivertebral nerve 622 to perform a localized treatment viadelivery of a therapeutic level of heating to stimulate or ablate thebasivertebral nerve 622.

In one embodiment, the RF energy is delivered to the treatment site viaelectrodes 564, and activated to deliver therapeutic treatment energy.In one embodiment, the treatment probe comprises an RF delivery probehaving bipolar electrodes.

In accordance with several embodiments, any number of treatmentmodalities may be delivered to the treatment site for therapeutictreatment. For example, treatment may be affected by monopolar, tripolaror sesquipolar RF, ultrasound, radiation, steam, microwave, laser, orother heating means. In one embodiment, the treatment device comprises afluid delivery catheter that deposits an agent (e.g., bone cement, orother therapeutic agent) to the treatment site T.

In accordance with several embodiments, cryogenic cooling (not shown)may be delivered for localized treatment of the basivertebral nerve.Furthermore, treatment may be affected by any mechanical destruction andor removal means capable of severing or denervating the basivertebralnerve. For example, a cutting blade, bur or mechanically actuated cutter(not shown) typically used in the art of orthoscopic surgery may be usedto affect denervation of the basivertebral nerve.

In addition to or separate from treating the basivertebral nerve, asensor (not shown) may be delivered to the region to preoperatively orpostoperatively measure nerve conduction at the treatment region. Inthis configuration, the sensor may be delivered on a distal tip of aflexible probe that may or may not have treatment elements as well.

In other embodiments, the goal of the treatment may be ablation, ornecrosis of the target nerve or tissue, or some lesser degree oftreatment to denervate the basivertebral nerve. For example, thetreatment energy or frequency may be just sufficient to stimulate thenerve to block the nerve from transmitting signal (e.g. signalsindicating pain).

Once the treatment is complete, the curved probe 550 may be withdrawninto the cannula. The needle trocar 550 with the curved cannula 550 isthen removed and the access site is closed as prescribed by thephysician.

In accordance with several embodiments, the above systems 10, 200, 201,300, 400, and 510 may be provided as a kit of instruments to treatdifferent regions of the body. As one example, the varying of location,orientation, and angle may be achieved by varying the curvature in thecurved or curveable cannula (e.g., 230, 322, 430, or 550). The curvaturemay be varied by varying the radius of curvature, the insertion depth(shaft length and tip length), and/or the final exit angle with respectto the trocar channel 528. Thus, the physician may select a differentkit for treating a lumber spine segment as opposed to a cervical spinesegment, as the anatomy may dictate the path that needs to be channeled.

In accordance with several embodiments, each of the components in thesystems 10, 200, 201, 300, 400 and 510 may have any length, shape, ordiameter desired or required to provide access to the treatment and/ordiagnostic region (e.g. intraosseous nerve or basivertebral nerve trunk)thereby facilitating effective treatment and/or diagnostic of the targetregion. For example, the size of the intraosseous nerve to be treated,the size of the passageway in the bone (e.g. pedicle 138 or 638) foraccessing the intraosseous nerve, and the location of the bone (and thusthe intraosseous nerve) are factors that that may assist in determiningthe desired size and shape of the individual instruments. In severalembodiments, the treatment device (e.g., RF probe) has a diameterbetween 1 mm and 5 mm (e.g., between 1 mm and 3 mm, between 2 mm and 4mm, between 3 mm and 5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, or any diameterbetween the recited ranges).

In accordance with several embodiments, the systems 10, 200, 201, 300,400, and 510 described above may be used with a number of differenttreatment modalities for therapeutic treatment of the target region,which may be spinal or non-spinal. For example, in one embodiment, it isdesirable to operate the treatment devices or probes in system 10, 200,201, 300, 400, and 510 in a manner that ablates the tissue of the targetregion (e.g. basivertebral nerve) to produce heat as described in U.S.Pat. No. 6,699,242, herein incorporated by reference in its entirety.

In another embodiment, the treatment device is configured to delivertherapeutic treatment that is targeted to block nerve conduction withoutablating the nerve, i.e. thermal treatment is delivered to the nerve(e.g. via thermal therapy, agent or the like) that results indenervation of the basivertebral nerve without necrosis of tissue. Thismay be achieved via delivery of a lesser amount of energy or agent tothe tissue site (either in the form of less exposure time,concentration, intensity, thermal dose etc.) than is required forablation, but an amount sufficient to achieve some amount of temporaryor permanent denervation.

In accordance with several embodiments, the probe described herein maycomprise non-therapy devices, such as diagnostic devises (e.g.ultrasound, cameras, or the like) to diagnose a region of tissueindependent of or in connection with treatment of the region of tissue.

In several embodiments, individual elements of any of the systems 10,200, 201, 300, 400, and 510 detailed above may be used interchangeablywhere applicable. For example, the curved stylet 60 shown in systems 10and 200 may be temporarily implemented in place of the probe of systems201 and 300 to provide additional curving bias to the curveable cannula(230, 320) while the cannula is being driven into the bone. Furthermore,the channeling stylet 90 may be used to further generate a channelbeyond the curved path provided by the curveable cannula (230, 320).

Several embodiments of a steerable devices or systems (e.g., including adistal treatment probe and a proximal handle) for actuatingcurvature/steering of the distal probe are shown in FIGS. 36 through 42.It is further envisioned that any of the distal probe designs areinterchangeable with the proximal handle designs so that no one handledesign is specific to a distal probe design, and vice-versa. Inaccordance with at least one embodiment, the system is configured togenerate a curved path in bone, and in particular a path entering thevertebra from the pedicle and curving into the vertebral body to thetreatment location at the basivertebral nerve plexus. In accordance withseveral embodiments, the steerable systems described herein are robustenough to travel through bone as well as articulate within the bone.

FIGS. 36A-36D illustrate an embodiment of a steerable probe 700 with aproximal handle 710 having a thumb wheel 790 that is configured tooperate steering of a distal end 701 of the probe. In one embodiment,the proximal handle 710 includes one or two thumb wheels 790 which areinterconnected. In one embodiment, rotation of the thumb wheel 790drives linear motion of a pull wire 711 via a rack 730 and pinion 735.In some embodiments, the steerable probe 700 comprises electrode wiring713, electrode lead 715, engagement teeth 731, 736 between the rack 730and pinion 735, and a pull wire 711 embedded within the rack 730. Thebottom side of the rack 730 may have a series of notches 732 thatinterface with a protrusion 750 in the handle 710 to generate aresistive “click type” motion of the thumb wheel 790. As shown in FIG.36A, the thumb wheel 790 may have one or more markings or indicia 799 ofvarious degrees of curvature for the distal end 701. In one embodiment,the proximal end of the handle 710 includes a strike surface 780 forhammering the distal end 701 through cortical bone.

As shown in FIG. 36B, one embodiment of the steerable probe 700 mayinclude tubular electrodes 760, 762, a pull wire 711 and a central tube720 (e.g., a hypotube) that is laterally slotted 721 to allow the tube720 to bend upon actuation of the pull wire 711, while still providingaxial rigidity to allow the distal end 701 to be tapped through bone.

FIGS. 37A-37C illustrates an embodiment of a steerable probe 800 with ahypotube 820 that is laterally slotted 821 to allow the hypotube 820 tobend upon actuation of pull wire 811, along with slots and/or relief forwiring. The distal end of the steerable probe 800 may include a conicaldistal tip 802 and tubular electrodes 860, 862. FIG. 37B illustrates aside view of the steerable probe 800 showing electrode wiring 813 withina lumen 823 of the hypotube 820. In various embodiments, the hypotube820 comprises stainless steel or DELRIN® material. In variousembodiments of manufacture, an outer layer 840 of PEBAX® (a blockcopolymer which offers a wide range of performances among thermoplasticelastomers) or other copolymer or thermoplastic elastomer material isdeposited between the electrodes 860, 862 and formed to have a diameterthat is flush with the outer diameter of the electrodes 860, 862. Insome embodiments, the outer layer 840 comprises a lumen 841 for the pullwire 811, a lumen 845 for electrode lead wiring 815, and a centralchannel 842 (e.g., for the hypotube 820). In some embodiments, the outerlayer 840 comprises a pocket to house electrode lead wiring 815 and/orelectrode wiring 813. In some embodiments, the hypotube 820 includes anoval slot for electrode lead wiring 815 and/or electrode wiring 813. Insome embodiments, the outer layer 840 comprises an overmolded tip ontohypotube 820 near the distal tip 802, as shown in FIG. 37C.

FIGS. 38A-38C illustrate embodiments of a steerable device proximalhandle 810 with a more ergonomic design and a larger thumb wheel 890.Rotation of the thumb wheel 890 may be configured to operate steering ofthe distal end 801 of a probe, and in some embodiments, bend the tip802. In one embodiment, the thumb wheel 890 is spring loaded axially viaa spring 891 to retain the thumb wheel 890 in a radially locked positionwith respect to handle 810 (e.g. via pall notched wheel 892 and detent893). Referring to FIG. 38B, in accordance with several embodiments, toactuate curvilinear motion of the distal end 801 of the probe, the thumbwheel 890 is pushed inward toward the proximal handle 810 to compressthe spring 891 and disengage the detent 893 from the pall notched wheel892, thereby allowing for rotation of the thumb wheel 890. The thumbwheel 890 drives linear motion of a pull wire 811. In some embodiments,the pull wire 811 is embedded within the pall notched wheel 892.

FIG. 38B illustrates an embodiment where the linear motion of the pullwire 811 is driven by the notched wheel 892. In some embodiments, thepull wire 811 is embedded within the rack 830. FIG. 38C illustrates anembodiment where the linear motion of the pull wire 811 is driven via arack 830 and pinion 835. In one embodiment, the hypotube 820 is fixedwith respect to the rack 830 and the pull wire 811 is retracted and/orextended based on radial motion of thumb wheel 890, which drives pinion835. The rack 830 and pinion 835 may be interchangeable with othercomponents in different embodiments.

FIGS. 39A-39D illustrate an embodiment of a steerable probe 9900proximal handle 9910, which may have markings or indicia 9999 of presetangles of curvature for the distal end (e.g., 0, 30, 60, and 90 degrees)in “stick shift” type configuration. As illustrated in FIG. 39D, theknob 9980 is mounted on the hypotube 9920 and is freely rotatable tonavigate the curved slots 9932. The knob 9980 may be spring loaded viasprings 9991 to restrain/retain the knob 9980 in respective slots 9932at given increments. In some embodiments, a pull wire 9911 is embeddedwithin the knob 9980. In some embodiments, the pull wire 9911 has abulbous end that is retained within the knob 9980, as illustrated inFIG. 39D. As the knob 9980 is moved, the pull wire 9911 may be retractedto allow the distal end to bend upon actuation of pull wire 9911.Several embodiments may include a strike surface 9980 located atproximal end of handle 9910 (e.g., for hammering the distal end throughcortical bone). In several embodiments, leads 9913 may be wired througha center piece of the strike surface 9980.

In one embodiment, not shown, an actuation knob is spring loaded torestrain/retain the knob in respective slots at given increments (e.g.,in an “escalating ladder” embodiment). The handle 9910 may have astationary rail and a spring retainer that slides along the stationaryrail. As the knob is moved toward the 90 degree marking, the pull wiremay be retracted to allow the distal end to bend upon actuation of thepull wire. This escalating ladder embodiment may allow the knob to cometo rest at certain preset locations on the handle 9910. In oneembodiment, the steerable probe 9900 comprises curved slots 9932.

FIGS. 40A-40C illustrate several embodiments of the distal end 9101 of asteerable probe 9100. In accordance with several embodiments, the distalend 9101 may have a furled ceramic distal tip 9102 for guiding a probethrough a curved path in bone. In addition, a laser-welded pull wire9111 may be wrapped around a distal end of the furled tip 9102 justproximal to the curvature at a relieved circumferential channel 9132.The proximal end of the furled tip 9102 may comprise reflow channels9122 for coupling to the polymeric outer structure 9140. In oneembodiment, the polymeric (e.g., PEBAX®) outer structure 9140 forms asingular unit with separate lumens for a pull wire and/or electrodewiring (not shown). The polymeric outer structure 9140 may compriselateral circumferential grooves 9141 between the electrodes 9160, 9162to promote lateral bending. In one embodiment, this configuration may beinserted into a vertebral channel after the cortical shell has beenpierced by a sharp stylet or the like. In one embodiment, at least twoinstruments are necessary to generate a curved path to the treatmentsite (e.g., a sharp stylet and a sleeve for guiding instruments).

FIGS. 41A-41E illustrate an embodiment of a steerable probe distal end9201 comprising a steerable sleeve 9240 and a passively-steeredtreatment probe 9220. In one embodiment, the steerable sleeve 9240comprises a bendable tube (e.g., PEBAX®) having a trocar channel sizedto receive the treatment probe 9220, and a lumen in the sidewall forreceiving and allowing reciprocation of the guidewire 9211. In oneembodiment, the guidewire 9211 is laser welded to an endcap 9202 that isdisposed at the distal end 9201 of the tube 9240. In one embodiment, theendcap 9202 is stainless steel. In one embodiment, the endcap 9202 has aspherical radius, as illustrated in FIG. 41C. In one embodiment, thetreatment probe 9220 comprises an elongate shaft (e.g., DELRIN®, alsoknown as polyoxymethylene, acetal, polyacetal, and polyformaldehyde)having lateral slots 9221 to promote bending in one direction (ormultiple directions in another embodiment). FIG. 41B illustrates oneembodiment of tubular electrodes 9260 of a steerable probe 9200. In oneembodiment, the elongate shaft comprises a spherical electrode tip 9261,wherein the elongate shaft has a relief proximal to the distal tip forhousing a tubular electrode 9260. The elongate shaft may comprise acentral channel for electrode wiring 9213 and electrode lead 9215. Inother embodiments, the elongate shaft may be comprised of a differentthermoplastic which demonstrates high stiffness and low frictioncharacteristics (e.g., Celcon® or Hostaform®).

In one embodiment, during operation, the treatment probe 9220 isconfigured to be disposed within the steerable sleeve 9240 so that thespherical tip of the electrode 9261 protrudes out of the distal end ofthe central channel of the sleeve 9240, and acts as a stylet while theprobe 9220 and sleeve 9240 are guided in a curved path to the treatmentsite. Prior to delivery of the treatment probe 9220, a sharp stylet (notshown) may be inserted in the sleeve 9240 for piercing the outercortical shell of the vertebral body. The stylet may then be removed andthe treatment probe 9220 may be inserted for delivery to the treatmentsite via a steered, curved path. Upon reaching the treatment site, thesleeve 9240 may be retracted (or probe 9220 advanced) to expose thesecond of two bipolar electrodes for treatment.

FIGS. 42A-42B illustrate an embodiment of a steerable probe 900 with asteerable probe distal end 901 comprising a single-instrument designwith a steerable inner probe 920 and a retractable sleeve 940. Thesteerable probe 900 comprises a sharp distal tip 902 for piercing acortical shell and channeling a path through cancellous bone. In oneembodiment, attached proximal to the sharp distal tip 902 is a helicaltubular segment 924 that provides lateral bendability, while beingaxially stiff when the sheath is in the position shown in FIG. 42B. Asshown in FIG. 42A, a pull wire 911 may be coupled to the distal tip 902,with channeling through polymer spacers 925. In one embodiment, twospaced apart tubular electrodes 960, 962 surround a helical segment 924just proximal to the distal end and have a layer of polymer 926 disposedbetween the electrodes 960, 962 and the helical segment 924 as shown inFIG. 42A. The sheath 940 may be disposed in the distal position asillustrated in FIG. 42A for channeling, and then retracted to allow forelectrodes to be exposed for treatment.

FIG. 42C illustrates an embodiment of a curved stylet 7500 (e.g.,J-shaped stylet) capable of use with any of the systems (e.g., bonechanneling, intraosseous nerve access and/or neuromodulation systems)described herein. The curved stylet 7500 comprises an inner core 7510and an outer tube 7520. In several embodiments, the inner core 7510comprises an elastic metal alloy (e.g., nitinol, stainless steel, etc.).The diameter 7511 of the inner core 7510 may be in the range of about0.010″ to about 0.080″ (e.g., 0.010″ to 0.050″, 0.015″ to 0.045″, 0.020″to 0.080″, 0.025″ to 0.075″, 0.030″ to 0.080″, 0.050″ to 0.080″, 0.010″to 0.030″, or overlapping ranges thereof). In one embodiment, thediameter 7511 is constant along the entire length of the inner core7510. In several embodiments, the outer tube 7520 comprises a polymer(e.g., PEEK, PEBAX®, polyolefin, etc.). The range of wall thickness 7521of the outer tube 7520 may be in the range of about 0.005″ to about0.040″. In some embodiments, the overall diameter of the stylet 7500 isabout 0.090″. In one embodiment the overall diameter of the stylet 7500is constant along the entire length of the stylet 7500, advantageouslyallowing the stylet 7500 to conform to the inner diameter along theentire length of a cannula (e.g., any of the curved or curveablecannulas described herein). If the overall diameter were to beincreased, then the range of the wall thickness and diameter of innercore may also both increase. In accordance with several embodiments, thestiffness of the stylet 7500 can advantageously be altered bymanipulating the diameter 7511 of the inner core 7510, manipulating thewall thickness 7521 of the outer tube 7520, or a combination of both. Insome embodiments, the distal tip of the stylet 7500 is angled but notsharp. In one embodiment, the distal tip of the stylet 7500 is at leastpartially rounded or blunt. In some embodiments, outer tube 7520 extendslaterally beyond inner core 7510 and surrounds the distal tip of theinner core 7510. When the stylet 7500 is disposed within a cannula,lumen or hypotube of any previous embodiment, the stylet 7500 may be incontact with and provide lateral support for the cannula, lumen orhypotube.

In general, it may be desirable to operate embodiments of the inventionin a manner that produce a peak temperature in the target tissue ofbetween about 80° C. and 95° C. When the peak temperature is below 80°C., the off-peak temperatures may quickly fall below about 45° C. Whenthe peak temperature is above about 95° C., the bone tissue exposed tothat peak temperature may experience necrosis and produce charring. Thischarring reduces the electrical conductivity of the charred tissue,thereby making it more difficult to pass RF current through the targettissue beyond the char and to resistively heat the target tissue beyondthe char. In some embodiments, the peak temperature is between 86° C.and 94° C., between 80° C. and 90° C., 85° C., overlapping rangesthereof, or any temperature value between 80° C. and 95° C.

It may be desirable to heat the volume of target tissue to a minimumtemperature of at least 42° C., in accordance with several embodiments.When the tissue experiences a temperature above 42° C., nerves withinthe target tissue may be desirably damaged. However, it is believed thatdenervation is a function of the total quantum of energy delivered tothe target tissue; i.e., both exposure temperature and exposure timedetermine the total dose of energy delivered.

Typically, the period of time that an intraosseous nerve is exposed totherapeutic temperatures is in general related to the length of time inwhich the electrodes are activated. In some embodiments, the electrodes,when the peak temperature is between 80° C. and 95° C., may be activatedbetween 10 and 20 minutes, between 10 and 15 minutes, 12 minutes, 15minutes, less than 10 minutes, greater than 20 minutes, or any durationof time between 10 and 20 minutes, to achieve the minimum target tissuetemperature such that the nerve tissue is modulated (e.g., denervated).However, since it has been observed that the total heating zone remainsrelatively hot even after power has been turned off (and the electricfield eliminated), the exposure time can include a period of time inwhich current is not running through the electrodes.

In general, the farther apart the electrodes, the greater the likelihoodthat the ION will be contained within the total heating zone. Therefore,in some embodiments the electrodes are placed at least 5 mm apart or atleast 10 mm apart. However, if the electrodes are spaced too far apart,the electric field takes on an undesirably extreme dumbbell shape.Therefore, in many embodiments, the electrodes are placed apart adistance of between 1 mm and 25 mm, between 5 mm and 15 mm, between 10mm and 15 mm between 3 mm and 10 mm, between 8 mm and 13 mm, between 10mm and 18 mm, between 12 mm and 20 mm between 20 and 25 mm, between 1 mmand 3 mm, or any integer or value between 1 mm and 25 mm.

In some embodiments, it is desirable to heat the target tissue so thatat least about 1 cc of bone tissue experiences the minimum temperature.This volume corresponds to a sphere having a radius of about 0.6 cm.Alternatively stated, it is desirable to heat the target tissue so theminimum temperature is achieved by every portion of the bone within 0.6cm of the point experiencing the peak temperature.

In accordance with several embodiments, it is desirable to heat thetarget tissue so that at least about 3 cc of bone experiences theminimum temperature. This volume corresponds to a sphere having a radiusof about 1 cm (e.g., 0.7 cm, 0.8 cm. 0.9 cm, 1.0 cm, 1.1 cm, 1.2 cm, 1.3cm, 1.4 cm).

Some embodiments provide a steady-state heated zone having a peaktemperature of between 80° C. and 95° C. (e.g., between 86° C. and 94°C., between 80° C. and 90° C., or overlapping ranges thereof), and heatat least 1 cc of bone (e.g., at least 2 cc of bone, at least 3 cc ofbone, at least 4 cc of bone, at least 5 cc of bone) to a temperature ofat least 50° C. (e.g., 60° C.).

In accordance with several embodiments, a method of therapeuticallytreating a vertebral body having a basivertebral nerve comprisesproviding an energy device having an active and a return electrode,inserting the active electrode into the vertebral body, inserting thereturn electrode into the vertebral body, and applying a sufficientlyhigh frequency voltage difference between the active and returnelectrodes to generate a current therebetween to produce a total heatingzone having a diameter of at least 0.5 cm and a steady state temperatureof at least 50° C.

As noted above, a peak temperature below about 100° C. or below about105° C. is desirable in order to prevent charring of the adjacenttissue, steam formation and tissue popping. In some embodiments, this isaccomplished by providing the power supply with a feedback means thatallows the peak temperature within the heating zone to be maintained ata desired target temperature, such as 90° C. In some embodiments, thepeak temperature is in the range of 85° C. to 95° C. In otherembodiments, the peak temperature is between about 70° C. and 90° C.

In some embodiments, between about 24 watts and 30 watts of power isfirst supplied to the device in order to rapidly heat the relativelycool bone, with maximum amperage being obtained within about 10-15seconds. In other embodiments, between about 28 watts and 32 watts ofpower, between about 20 watts and 26 watts of power, between 30 wattsand 40 watts of power, between 15 watts and 24 watts of power,overlapping ranges thereof, or any power level within the ranges, isfirst supplied to the device. In some embodiments, the maximum amperagemay be obtained within 5-10 seconds, within about 15-25 seconds, withinabout 7-12 seconds, within about 13-18 seconds, overlapping rangesthereof, or any duration within the recited ranges. As the bone isfurther heated to the target temperature, the feedback means graduallyreduces the power input to the device to between about 6-10 watts. Insome embodiments, the power input is reduced to between 4-7 watts, about8-12 watts, between 2-6 watts, between about 7-15 watts, or overlappingranges thereto.

Cooling may be employed for any of the neuromodulation devices (e.g.,energy delivery devices) described herein. In several embodiments, acooling balloon or other cooling device or fluid (e.g., heat removalelements, heat sinks, cooling fluid circulating through one or morelumens of the neuromodulation device) is used for cooling the treatmentzone or location or the area surrounding the treatment zone or location.

If the active electrode has no active cooling means, it may becomesubject to conductive heating by the heated tissue, and the resultantincreased temperature in the electrode may adversely affect performanceby charring the adjacent bone tissue. Accordingly, in some embodiments,a cool tip active electrode may be employed. The cooled electrode helpsmaintain the temperature of the electrode at a desired temperature.Cooled tip active electrodes are known in the art. Alternatively, thepower supply may be designed to provide a pulsed energy input. It hasbeen found that pulsing the current favorably allows heat to dissipatefrom the electrode tip, and so the active electrode stays relativelycooler.

In various embodiments, the neuromodulation device comprises anelectrosurgical probe having a shaft with a proximal end, a distal end,and at least one active electrode at or near the distal end. A connectormay be provided at or near the proximal end of the shaft forelectrically coupling the active electrode to a high frequency voltagesource. In some embodiments, a return electrode coupled to the voltagesource is spaced a sufficient distance from the active electrode tosubstantially avoid or minimize current shorting therebetween. Thereturn electrode may be provided integral with the shaft of the probe orit may be separate from the shaft

In some embodiments, the electrosurgical probe or catheter comprises ashaft or a handpiece having a proximal end and a distal end whichsupports one or more electrode terminal(s). The shaft or handpiece mayassume a wide variety of configurations, with the primary purpose beingto mechanically support the active electrode and permit the treatingphysician to manipulate the electrode from a proximal end of the shaft.The shaft may be rigid or flexible, with flexible shafts optionallybeing combined with a generally rigid external tube for mechanicalsupport. Flexible shafts may be combined with pull wires, shape memoryactuators, and other known mechanisms for effecting selective deflectionof the distal end of the shaft to facilitate positioning of theelectrode array. The shaft will usually include a plurality of wires orother conductive elements running axially therethrough to permitconnection of the electrode array to a connector at the proximal end ofthe shaft.

In several embodiments, the shaft is a rigid needle that is introducedthrough a percutaneous penetration in the patient. However, forendoscopic procedures within the spine, the shaft may have a suitablediameter and length to allow the surgeon to reach the target site (e.g.,a disc) by delivering the shaft through the thoracic cavity, the abdomenor the like. Thus, the shaft may have a length in the range of about 5.0to 30.0 cm (e.g., about 5-10, 10-15, 10-20, or 10-30 cm, or overlappingranges thereof), and a diameter in the range of about 0.2 mm to about 10mm (e.g., about 0.2-1, 1-2, 2-4, 2-6, 6-8, or 5-10 mm, or overlappingranges thereof). In any of these embodiments, the shaft may also beintroduced through rigid or flexible endoscopes.

The probe may include one or more active electrode(s) for applyingelectrical energy to tissues within the spine. The probe may include oneor more return electrode(s), or the return electrode may be positionedon the patient's back, as a dispersive pad. In either embodiment,sufficient electrical energy is applied through the probe to the activeelectrode(s) to either necrose the blood supply or nerves within thevertebral body.

The electrosurgical instrument may also be a catheter that is deliveredpercutaneously and/or endoluminally into the patient by insertionthrough a conventional or specialized guide catheter, or the inventionmay include a catheter having an active electrode or electrode arrayintegral with its distal end. The catheter shaft may be rigid orflexible, with flexible shafts optionally being combined with agenerally rigid external tube for mechanical support. Flexible shaftsmay be combined with pull wires, shape memory actuators, and other knownmechanisms for effecting selective deflection of the distal end of theshaft to facilitate positioning of the electrode or electrode array. Thecatheter shaft may include a plurality of wires or other conductiveelements running axially therethrough to permit connection of theelectrode or electrode array and the return electrode to a connector atthe proximal end of the catheter shaft. The catheter shaft may include aguide wire for guiding the catheter to the target site, or the cathetermay comprise a steerable guide catheter. The catheter may also include asubstantially rigid distal end portion to increase the torque control ofthe distal end portion as the catheter is advanced further into thepatient's body. Specific deployment means will be described in detail inconnection with the figures hereinafter.

In some embodiments, the electrically conductive wires may run freelyinside the catheter bore in an unconstrained made, or within multiplelumens within the catheter bore.

The tip region of the instrument may comprise many independent electrodeterminals designed to deliver electrical energy in the vicinity of thetip. The selective application of electrical energy is achieved byconnecting each individual electrode terminal and the return electrodeto a power source having independently controlled or current limitedchannels. The return electrode(s) may comprise a single tubular memberof conductive material proximal to the electrode array. Alternatively,the instrument may comprise an array of return electrodes at the distaltip of the instrument (together with the active electrodes) to maintainthe electric current at the tip. The application of high frequencyvoltage between the return electrode(s) and the electrode array resultsin the generation of high electric field intensities at the distal tipsof the electrode terminals with conduction of high frequency currentfrom each individual electrode terminal to the return electrode. Thecurrent flow from each individual electrode terminal to the returnelectrode(s) is controlled by either active or passive means, or acombination thereof, to deliver electrical energy to the surroundingconductive fluid while minimizing or preventing energy delivery tosurrounding (non-target) tissue, such as the spinal cord.

Temperature probes associated with the apparatus may be disposed on orwithin the electrode carrier; between the electrodes (may be preferredin bipolar embodiments); or within the electrodes (may be preferred formonopolar embodiments). In some embodiments wherein the electrodes areplaced on either side of the ION, a temperature probe is disposedbetween the electrodes or in the electrodes. In alternate embodiments,the deployable portion of the temperature probe comprises a memorymetal.

The electrode terminal(s) may be supported within or by an inorganicinsulating support positioned near the distal end of the instrumentshaft. The return electrode may be located on the instrument shaft, onanother instrument or on the external surface of the patient (i.e., adispersive pad). In some embodiments, the close proximity of the dualneedle design to the intraosseous nerve makes a bipolar design morepreferable because this minimizes the current flow through non-targettissue and surrounding nerves. Accordingly, the return electrode may beeither integrated with the instrument body, or another instrumentlocated in close proximity thereto. The proximal end of theinstrument(s) may include the appropriate electrical connections forcoupling the return electrode(s) and the electrode terminal(s) to a highfrequency power supply, such as an electrosurgical generator.

In some embodiments, the active electrode(s) have an active portion orsurface with surface geometries shaped to promote the electric fieldintensity and associated current density along the leading edges of theelectrodes. Suitable surface geometries may be obtained by creatingelectrode shapes that include sharp edges, or by creating asperities orother surface roughness on the active surface(s) of the electrodes.Electrode shapes can include the use of formed wire (e.g., by drawinground wire through a shaping die) to form electrodes with a variety ofcross-sectional shapes, such as square, rectangular, L or V shaped, orthe like. The electrodes may be tip electrodes, ring electrodes, plateelectrodes, cylindrical electrodes, frustoconical electrodes, or anyother shape electrodes. Electrode edges may also be created by removinga portion of the elongate metal electrode to reshape the cross-section.For example, material can be ground along the length of a round orhollow wire electrode to form D or C shaped wires, respectively, withedges facing in the cutting direction. Alternatively, material can beremoved at closely spaced intervals along the electrode length to formtransverse grooves, slots, threads or the like along the electrodes. Inother embodiments, the probe can be sectored so that a givencircumference comprises an electrode region and an inactive region. Insome embodiments, the inactive region is masked.

The return electrode is, in several embodiments, spaced proximally fromthe active electrode(s) a suitable distance. In most of the embodimentsdescribed herein, the distal edge of the exposed surface of the returnelectrode is spaced about 1 to 25 mm (or any distance therebetween) fromthe proximal edge of the exposed surface of the active electrode(s), indual needle insertions. Of course, this distance may vary with differentvoltage ranges, the electrode geometry and depend on the proximity oftissue structures to active and return electrodes. In severalembodiments, the return electrode has an exposed length in the range ofabout 1 to 20 mm, about 2 to 6 mm, about 3 to 5 mm, about 1 to 8 mm,about 4 to 12 mm, about 6 to 16 mm, about 10 to 20 mm, 4 mm, 5 mm, 10mm, or any length between 1 and 20 mm. The application of a highfrequency voltage between the return electrode(s) and the electrodeterminal(s) for appropriate time intervals effects modifying the targettissue. In several embodiments, the electrodes have an outer diameter ofbetween 1 and 2 mm (e.g., between 1 and 1.5 mm, between 1.2 and 1.8 mm,between 1.5 and 1.7 mm, between 1.6 and 2 mm, 1.65 mm, or any outerdiameter between the recited ranges). In several embodiments, theelectrodes have an inner diameter of between 0.5 and 1.5 mm (e.g.,between 0.5 and 0.8 mm, between 0.75 and 0.9 mm, between 0.8 and 1 mm,between 1 mm and 1.5 mm, 0.85 mm, or any inner diameter between therecited ranges).

Embodiments may use a single active electrode terminal or an array ofelectrode terminals spaced around the distal surface of a catheter orprobe. In the latter embodiment, the electrode array usually includes aplurality of independently current limited and/or power-controlledelectrode terminals to apply electrical energy selectively to the targettissue while limiting the unwanted application of electrical energy tothe surrounding tissue and environment resulting from power dissipationinto surrounding electrically conductive fluids, such as blood, normalsaline, and the like. The electrode terminals may be independentlycurrent-limited by isolating the terminals from each other andconnecting each terminal to a separate power source that is isolatedfrom the other electrode terminals. Alternatively, the electrodeterminals may be connected to each other at either the proximal ordistal ends of the catheter to form a single wire that couples to apower source.

In one configuration, each individual electrode terminal in theelectrode array is electrically insulated from all other electrodeterminals in the array within said instrument and is connected to apower source which is isolated from each of the other. electrodeterminals in the array or to circuitry which limits or interruptscurrent flow to the electrode terminal when low resistivity material(e.g., blood) causes a lower impedance path between the return electrodeand the individual electrode terminal. The isolated power sources foreach individual electrode terminal may be separate power supply circuitshaving internal impedance characteristics which limit power to theassociated electrode terminal when a low impedance return path isencountered. By way of example, the isolated power source may be a userselectable constant current source. In one embodiment, lower impedancepaths may automatically result in lower resistive heating levels sincethe heating is proportional to the square of the operating current timesthe impedance. Alternatively, a single power source may be connected toeach of the electrode terminals through independently actuatableswitches, or by independent current limiting elements, such asinductors, capacitors, resistors and/or combinations thereof. Thecurrent limiting elements may be provided in the instrument, connectors,cable, controller, or along the conductive path from the controller tothe distal tip of the instrument. Alternatively, the resistance and/orcapacitance may occur on the surface of the active electrode terminal(s)due to oxide layers which form selected electrode terminals (e.g.,titanium or a resistive coating on the surface of me till, such asplatinum).

In one embodiment of the invention, the active electrode comprises anelectrode array having a plurality of electrically isolated electrodeterminals disposed over a contact surface, which may be a planar ornon-planar surface and which may be located at the distal tip or over alateral surface of the shaft, or over both the tip and lateralsurface(s). The electrode array may include at least two or moreelectrode terminals and may further comprise a temperature sensor. Inone embodiment, each electrode terminal may be connected to the proximalconnector by an electrically isolated conductor disposed within theshaft. The conductors permit independent electrical coupling of theelectrode terminals to a high frequency power supply and control systemwith optional temperature monitor for operation of the probe. Thecontrol system may advantageously incorporate active and/or passivecurrent limiting structures, which are designed to limit current flowwhen the associated electrode terminal is in contact with a lowresistance return path back to the return electrode.

In one embodiment, the use of such electrode arrays in electrosurgicalprocedures may be particularly advantageous as it has been found tolimit the depth of tissue necrosis without substantially reducing powerdelivery. The voltage applied to each electrode terminal causeselectrical energy to be imparted to any body structure which iscontacted by, or comes into close proximity with, the electrodeterminal, where a current flow through all low electrical impedancepaths may be limited. Since some of the needles are hollow, a conductivefluid could be added through the needle and into the bone structure forthe purposes of lowering the electrical impedance and fill the spaces inthe cancellous bone to make them better conductors to the needle.

It should be clearly understood that embodiments of the invention arenot limited to electrically isolated electrode terminals, or even to aplurality of electrode terminals. For example, the array of activeelectrode terminals may be connected to a single lead that extendsthrough the catheter shaft to a power source of high frequency current.Alternatively, the instrument may incorporate a single electrode thatextends directly through the catheter shaft or is connected to a singlelead that extends to the power source. The active electrode(s) may haveball shapes, twizzle shapes, spring shapes, twisted metal shapes, coneshapes, annular or solid tube shapes or the like. Alternatively, theelectrode(s) may comprise a plurality of filaments, rigid or flexiblebrush electrode(s), side-effect brush electrode(s) on a lateral surfaceof the shaft, coiled electrode(s) or the like.

The voltage difference applied between the return electrode(s) and theelectrode terminal(s) can be at high or radio frequency (e.g., betweenabout 50 kHz and 20 MHz, between about 100 kHz and 2.5 MHz, betweenabout 400 kHz and 1000 kHz, less than 600 kHz, between about 400 kHz and600 kHz, overlapping ranges thereof, 500 kHz, or any frequency withinthe recited ranges. The RMS (root mean square) voltage applied may be inthe range from about 5 volts to 1000 volts, in the range from about 10volts to 200 volts, between about 20 to 100 volts, between about 40 to60 volts, depending on the electrode terminal size, the operatingfrequency and the operation mode of the particular procedure. Lowerpeak-to-peak voltages may be used for tissue coagulation, thermalheating of tissue, or collagen contraction and may be in the range from50 to 1500, from 100 to 1000, from 120 to 400 volts, from 100 to 250volts, from 200 to 600 volts, from 150 to 350 volts peak-to-peak,overlapping ranges thereof, or any voltage within the recited ranges. Asdiscussed above, the voltage may be delivered continuously with asufficiently high frequency (e.g., on the order of 50 kHz to 20 MHz) (ascompared with e.g., lasers claiming small depths of necrosis, which aregenerally pulsed about 10 to 20 Hz). In addition, the sine wave dutycycle (i.e., cumulative time in anyone-second interval that energy isapplied) may be on the order of about 100%, as compared with pulsedlasers which typically have a duty cycle of about 0.0001%. In variousembodiments, the current ranges from 50 to 300 mA (e.g., from 50 to 150mA, from 100 to 200 mA, from 150 to 300 mA, overlapping ranges thereof,or any current level within the recited ranges).

A power source may deliver a high frequency current selectable togenerate average power levels ranging from several milliwatts to tens ofwatts per electrode, depending on the volume of target tissue beingheated, and/or the maximum allowed temperature selected for theinstrument, tip. The power source allows the user to select the powerlevel according to the specific requirements of a particular procedure.

The power source may be current limited or otherwise controlled so thatundesired heating of the target tissue or surrounding (non-target)tissue does not occur. In one embodiment, current limiting inductors areplaced in series with each independent electrode terminal, where theinductance of the inductor is in the range of 10 uH to 50,000 uH,depending on the electrical properties of the target tissue, the desiredtissue heating rate and the operating frequency. Alternatively,capacitor-inductor (LC) circuit structures may be employed, as describedpreviously in U.S. Pat. No. 5,697,909. Additionally, current limitingresistors may be selected. In several embodiments, microprocessors areemployed to monitor the measured current and control the output to limitthe current.

The area of the tissue treatment surface can vary widely, and the tissuetreatment surface can assume a variety of geometries, with particularareas and geometries being selected for specific applications. Thegeometries can be planar, concave, convex, hemispherical, conical,linear “in-line” array or virtually any other regular or irregularshape. Most commonly, the active electrode(s) or electrode terminal(s)can be formed at the distal tip of the electrosurgical instrument shaft,frequently being planar, disk-shaped, ring-shaped, or hemisphericalsurfaces for use in reshaping procedures or being linear arrays for usein cutting. Alternatively or additionally, the active electrode(s) maybe formed on lateral surfaces of the electrosurgical instrument shaft(e.g., in the manner of a spatula), facilitating access to certain bodystructures in endoscopic procedures.

The devices may be suitably used for insertion into any hard tissue inthe human body. In some embodiments, the hard tissue is bone. In otherembodiments, the hard tissue is cartilage. In some embodiments when boneis selected as the tissue of choice, the bone is a vertebral body. Inseveral embodiments, devices are adapted to puncture the hard corticalshell of the bone and penetrate at least a portion of the underlyingcancellous bone. In some embodiments, the probe advances into the boneto a distance of at least ⅓ of the cross-section of the bone defined bythe advance of the probe. Some method embodiments are practiced invertebral bodies substantially free of tumors. In others, methodembodiments are practiced in vertebral bodies having tumors and may beused in conjunction with treatment of tumors.

Example

The following Example illustrates some embodiments of the invention andis not intended in any way to limit the scope of the disclosure.Moreover, the methods and procedures described in the followingexamples, and in the above disclosure, need not be performed in thesequence presented.

A pilot human clinical study was performed to determine efficacy of aminimally invasive technique involving ablation of the basivertebralnerve in providing relief to patients with chronic lower back pain.

In the present study, a radiofrequency device was used to ablate thenerves within the vertebral bone that transmit pain signals. The studyinvolved treatment of 16 human patients with chronic (greater than 6months) isolated lower back pain who were unresponsive to at least 3months of nonsurgical conservative care. The patients treated andobserved in the study were an average of 47.6 years old and hadundergone an average of 32.4 months of conservative treatment. Thepatients all had Oswestry Disability Index (ODI) scores greater than 30and either pathologic changes or positive provocative discography at thetargeted degenerated disc level.

In accordance with several embodiments, the intraosseous course of thebasivertebral foramen for the targeted vertebral bodies was visualizedand mapped using MRI imaging (e.g., anteroposterior and lateral stillimages). CT or other imaging techniques can also be used. In the study,treatment was performed using intraoperative fluoroscopy and atranspedicular approach; however, other visualization and approachtechniques can be used. The treatment device used during the study was abipolar radiofrequency probe with a curved obturator. In the study, thebipolar RF probe was inserted through a bone biopsy needle and guided tothe target treatment location under fluoroscopy. The bipolar RF probewas then used to ablate the basivertebral nerve in a controlled manner.The RF energy delivered in the study had a frequency of 500 kHz, thetemperature at the electrodes was 85° C., and the duration of treatmentvaried between 5 and 15 minutes. In accordance with several embodiments,the RF energy delivered may be between 400 and 600 kHz (e.g., 450 kHz,500 kHz, 550 kHz), the temperature at the electrodes may be between 80°C. and 100° C. (e.g., 85° C., 90° C., 95° C.), and the duration oftreatment may be between 4 and 20 minutes (e.g., 6 minutes, 8 minutes,10 minutes, 12 minutes, 15 minutes).

In accordance with several embodiments, the treatment was limited to theL3, L4, L5 and Si vertebrae. Two-level and three-level intraosseousablation treatments were performed on various patients. The multiplelevels treated during the study were at adjacent levels. Twelve patientswere treated at the L4 and L5 levels, two patients were treated at L3through L5 levels, and two patients were treated at the L5 and Silevels.

Radiographs found no factures during the follow-up period, and noremodeling of bone was observed. Thirteen of the sixteen patientsreported “profound and immediate relief.” The treatment procedureresulted in improved ODI scores and Visual Analogue Pain Scale (VAS)values, which were sustained at one year. ODI scores were significantlyimproved at six weeks, three months, six months, and twelve months. Themean decrease in ODI scores at 1 year was 31 points. VAS valuesdecreased from a preoperative average of 61.1 to an average of 45.6 atthe 1-year follow-up. No device-related serious adverse events werereported. Accordingly, in one embodiment, basivertebral nerve ablationis a safe, simple procedure that is applicable during the early stagesof treatment for patients with disabling back pain.

Conditional language, for example, among others, “can,” “could,”“might,” or “may,” unless specifically stated otherwise, or otherwiseunderstood within the context as used, is generally intended to conveythat certain embodiments include, while other embodiments do notinclude, certain features, elements and/or steps.

Although certain embodiments and examples have been described herein,aspects of the methods and devices shown and described in the presentdisclosure may be differently combined and/or modified to form stillfurther embodiments. Additionally, the methods described herein may bepracticed using any device suitable for performing the recited steps.Some embodiments have been described in connection with the accompanyingdrawings. However, it should be understood that the figures are notdrawn to scale. Distances, angles, etc. are merely illustrative and donot necessarily bear an exact relationship to actual dimensions andlayout of the devices illustrated. Components can be added, removed,and/or rearranged. Further, the disclosure (including the figures)herein of any particular feature, aspect, method, property,characteristic, quality, attribute, element, or the like in connectionwith various embodiments can be used in all other embodiments set forthherein.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures of the inventions are described herein. Embodiments embodied orcarried out in a manner may achieve one advantage or group of advantagesas taught herein without necessarily achieving other advantages. Theheadings used herein are merely provided to enhance readability and arenot intended to limit the scope of the embodiments disclosed in aparticular section to the features or elements disclosed in thatsection. The features or elements from one embodiment of the disclosurecan be employed by other embodiments of the disclosure. For example,features described in one figure may be used in conjunction withembodiments illustrated in other figures.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described and the appended claims.Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “delivering a therapeutic dose of energy” include“instructing the delivery of a therapeutic dose of energy.”

Various embodiments of the invention have been presented in a rangeformat. It should be understood that the description in range format ismerely for convenience and brevity and should not be construed as aninflexible limitation on the scope of the invention. The rangesdisclosed herein encompass any and all overlap, sub-ranges, andcombinations thereof, as well as individual numerical values within thatrange. For example, description of a range such as from about 5 to about30 minutes should be considered to have specifically disclosed subrangessuch as from 5 to 10 degrees, from 10 to 20 minutes, from 5 to 25minutes, from 15 to 30 minutes etc., as well as individual numberswithin that range, for example, 5, 10, 15, 20, 25, 12, 15.5 and anywhole and partial increments therebetween. Language such as “up to,” “atleast,” “greater than,” “less than,” “between,” and the like includesthe number recited. Numbers preceded by a term such as “about” or“approximately” include the recited numbers. For example, “about 10%”includes “10%.” For example, the terms “approximately”, “about”, and“substantially” as used herein represent an amount close to the statedamount that still performs a desired function or achieves a desiredresult.

1. (canceled)
 2. A method of ablating a nerve within a vertebral body,the method comprising: inserting an introducer into cancellous bone ofthe vertebral body, the introducer comprising a channel extendingthrough the introducer from a proximal end to a distal end; inserting aradiofrequency energy delivery probe through the channel of theintroducer and into the cancellous bone of the vertebral body, whereinthe radiofrequency energy delivery probe comprises: a proximal handle;an elongate member, the elongate member comprising a distal end portionthat is configured to deflect toward a target treatment location withinthe cancellous bone upon actuation by an operator; one or moreelectrodes; and a temperature sensor; and applying radiofrequency energyto the target treatment location via the one or more electrodessufficient to ablate the nerve within the vertebral body.
 3. The methodof claim 2, wherein: the distal end portion of the elongate membercomprises slots configured to facilitate bending of the distal endportion, the one or more electrodes comprises a bipolar pair ofelectrodes, and the nerve is a basivertebral nerve.
 4. The method ofclaim 2, wherein the distal end portion of the elongate member comprisesslots configured to facilitate bending of the distal end portion.
 5. Themethod of claim 2, wherein the radiofrequency energy delivery probecomprises a sharp distal tip.
 6. The method of claim 2, wherein thenerve is a basivertebral nerve.
 7. The method of claim 2, whereininserting the radiofrequency energy delivery probe through the channelof the introducer and into the cancellous bone of the vertebral bodycomprises creating a curved path to the target treatment location. 8.The method of claim 2, wherein the vertebral body is a lumbar vertebralbody, and wherein the target treatment location is in a posteriorsection of the lumbar vertebral body.
 9. The method of claim 2, whereinthe vertebral body is a sacral vertebral body, and wherein the targettreatment location is in a posterior section of the sacral vertebralbody.
 10. The method of claim 2, wherein the vertebral body is athoracic vertebral body, and wherein the target treatment location is ina posterior section of the thoracic vertebral body.
 11. The method ofclaim 2, wherein the proximal handle of the radiofrequency energydelivery probe comprises a thumb wheel.
 12. The method of claim 2,wherein the radiofrequency energy is configured to generate a peaktemperature at the target treatment location of between 70 and 90degrees Celsius, and wherein the radiofrequency energy is applied forbetween 5 and 30 minutes.
 13. A method of ablating a nerve within avertebral body, the method comprising: advancing an introducer throughcortical bone of the vertebral body and into cancellous bone of thevertebral body, the introducer comprising a proximal handle and anelongate tube comprising a channel, the channel extending from theproximal handle to a distal end of the introducer; inserting aradiofrequency energy delivery probe through the channel of theintroducer and into the cancellous bone of the vertebral body, whereinthe radiofrequency energy delivery probe comprises: a proximal handle;an elongate member, the elongate member comprising a steerable distalend portion that is configured to deflect upon actuation by an operator;one or more electrodes; and a sensor; positioning the steerable distalend portion at a target treatment location within the cancellous bone ofthe vertebral body corresponding to a portion of the vertebral body thatincludes at least a portion of the nerve; and applying radiofrequencyenergy to the target treatment location via the one or more electrodessufficient to ablate the nerve within the vertebral body.
 14. The methodof claim 13, wherein: the distal end portion of the elongate membercomprises slots configure to facilitate bending of the distal endportion, the nerve comprises a basivertebral nerve, and the targettreatment location comprises a location of a trunk of the basivertebralnerve.
 15. The method of claim 13, wherein the distal end portion of theelongate member comprises slots configure to facilitate bending of thedistal end portion.
 16. The method of claim 13, wherein the nervecomprises a basivertebral nerve.
 17. The method of claim 13, wherein thevertebral body is a lumbar or sacral vertebral body, and wherein thetarget treatment location is in a posterior section of the lumbar orsacral vertebral body.
 18. The method of claim 13, wherein theradiofrequency energy is configured to generate a peak temperature atthe target treatment location of between 70 and 90 degrees Celsius, andwherein the radiofrequency energy is applied for between 5 and 30minutes.
 19. A method of treating a nerve within a vertebral body, themethod comprising: advancing an introducer into cancellous bone of thevertebral body, the introducer comprising a proximal handle and anelongate tube comprising a channel, the channel extending from theproximal handle to a distal end of the introducer; inserting aradiofrequency energy delivery probe through the channel of theintroducer and into the cancellous bone of the vertebral body, whereinthe radiofrequency energy delivery probe comprises: an elongate member,the elongate member comprising a steerable distal end portion that isconfigured to deflect upon actuation by an operator; one or moreelectrodes; and a temperature sensor; positioning the steerable distalend portion of the elongate member of the radiofrequency energy deliveryprobe at a target treatment location within the cancellous bone of thevertebral body; and applying radiofrequency energy to the targettreatment location via the one or more electrodes sufficient to modulatethe nerve within the vertebral body.
 20. The method of claim 19, whereinthe radiofrequency energy is sufficient to ablate the nerve within thevertebral body.
 21. The method of claim 19, wherein: the distal endportion of the elongate member comprises slots configure to facilitatelateral bending of the distal end portion, the radiofrequency energy isconfigured to generate a peak temperature at the target treatmentlocation of between 70 and 90 degrees Celsius, the radiofrequency energyis applied for between 5 and 30 minutes, the nerve comprises abasivertebral nerve, and the one or more electrodes comprises twoelectrodes.